Vented vacuum bandage with irrigation for wound healing and method

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application No. 10/496,623 filed May 25, 2004 now U.S. Pat. No. 7,195,624 which is a US national counterpart application of international Application Ser. No. PCT/US02/41228 filed Dec. 20, 2002, which claims the benefit of U.S. Provisional Application Ser. No. 60/344,588 filed Dec. 26, 2001, U.S. Provisional Application Ser. No. 60/394,809 filed Jul. 10, 2002 and U.S. Provisional Application Ser. No. 60/394,970 filed Jul. 10, 2002, the disclosure of each of which is hereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

The present disclosure relates to vacuum therapy wound treatment systems including a vacuum bandage coupled to a vacuum source and an irrigation source.

The prior art contemplates that chronic wounds may be treated by providing a vacuum in the space above the wound to promote healing. A number of prior art references teach the value of the vacuum bandage or the provision of vacuum in the space above the surface of a chronic wound.

A vacuum bandage is a bandage having a cover for sealing about the outer perimeter of the wound and under which a vacuum is established to act on the wound surface. Applying vacuum to the wound surface promotes healing of chronic wounds. Typically, suction tubes are provided for drawing exudate away from the wound and for creating a vacuum under the cover. The following U.S. Patents establish the nature of vacuum treatment bandages and devices: U.S. Pat. Nos. 6,095,992; 6,080,189; 6,071,304; 5,645,081; 5,636,643; 5,358,494; 5,298,015; 4,969,880; 4,655,754; 4,569,674; 4,382,441; and 4,112,947. All of such references are incorporated herein by reference.

Further, the prior art contemplates that wounds may be treated by providing irrigation in the space above the wound. Typically, a tube is provided in communication with the wound surface of the wound at one end and with an irrigation source an another end. The fluid from the irrigation source travels through the tube to the wound surface.

The prior art further contemplates the use of stopcocks for use in intravenous injections and infusions. Stopcocks may be designed to include multiple ports for directing fluid flow along various paths or channels. The following U.S. Patents establish the nature of stopcocks: U.S. Pat. Nos. 6,158,467; 3,586,049; 2,485,842; 2,842,124; and 6,418,966.

SUMMARY OF THE INVENTION

The present invention comprises one or more of the following features or combinations thereof:

A wound care bandage system is provided for use with a wound. The system, among other things, may be capable of ventilating the wound. The system may include a vacuum source, an irrigation source, a vent in communication with the surrounding atmosphere and with the wound, and a bandage. The vacuum source creates negative pressure above the wound and the irrigation source irrigates the wound. As is herein defined, the term “vent” is or includes any passageway to the atmosphere, unless noted otherwise.

The bandage is configured to lie adjacent the wound to create a sealed environment about the wound. The vent may be positioned between the bandage and the vacuum source. A vacuum passageway of the system may extend between the bandage and the vacuum source, and a vent passageway of the system may extend from the bandage to the vent in communication with the surrounding atmosphere. The vacuum passageway may extend through the vent to the vacuum source.

The system may also include a multi-lumen tube which forms the vacuum passageway and the vent passageway, and a wound dressing member coupled to the multi-lumen tube configured to lie adjacent the wound. The multi-lumen tube may be configured to couple to the vacuum bandage and may include a venting lumen in communication with the surrounding atmosphere and another vacuum/irrigation lumen in communication with either or both of the vacuum source and the irrigation source. Further, the multi-lumen tube may include a vacuum lumen and a separate irrigation lumen distinct from the vacuum lumen.

The system may also include a vent-valve apparatus having the vent or a portion of the vent passageway formed therein. The apparatus provides selective communication between the wound and either the vacuum source or the irrigation source. The apparatus may include a multi-lumen connector configured to communicate with the bandage. The multi-lumen connector may include at least one inner conduit in communication with the vacuum source and/or the irrigation source and at least one outer conduit in communication with the atmosphere. The apparatus may further include a vacuum connector coupled to the vacuum source and an irrigation connector coupled to the irrigation source. An opening of the apparatus may be provided to communicate with the atmosphere and with the outer conduit of the multi-lumen connector.

In one embodiment, the apparatus may include a vent having the multi-lumen connector, and a stopcock coupled to the vent and including the vacuum connector and the irrigation connector. The vent may include a single-lumen connector coupled to the inner conduit of the multi-lumen connector. The vent may further include a housing and a filter housed within the housing. The filter may be in communication with the surrounding atmosphere and with the outer conduit of the multi-lumen connector through the opening.

The stopcock may include a single-lumen connector coupled to the single-lumen connector of the vent and a diverter to selectively couple the single-lumen connector of the stopcock with either the vacuum connector or with the irrigation connector. The stopcock may further include a body and the diverter may be coupled to the body for rotational movement relative to the body. The diverter may include a cut-out portion to selectively communicate the vacuum connector or the irrigation connector with the vent.

In another embodiment, the apparatus may include a body or outer shell defining an aperture and a diverter or inner barrel received within the aperture. The diverter may rotate relative to the outer shell to selectively communicate with the vacuum source or the irrigation source. The outer shell may include the multi-lumen connector, the vacuum connector, and the irrigation connector. The diverter may include a first set of passageways and a second set of passageways formed therethrough. The first set of passageways communicates with the inner conduit of the multi-lumen connector, the vacuum connector, and the irrigation connector. The second set of passageways may communicate with the outer conduit of the multi-lumen connector through a groove or channel formed in the outer shell between the outer conduit and the second set of passageways. The outer shell illustratively includes the opening of the apparatus and the second set of passageways is in selective communication with the opening. A filter may be coupled to the opening.

In yet another embodiment, the apparatus may include a vent and a stopcock coupled to the vent. The vent may include a multi-lumen connector and a first and second single-lumen connector. The stopcock may include a vacuum connector and an irrigation connector. The vacuum connector may include a first portion coupled to the first single-lumen connector of the vent and a second portion coupled to the vacuum source. The irrigation connector may include a first portion coupled to the second single-lumen connector of the vent and a second portion coupled to the irrigation source.

The inner conduit of the multi-lumen connector may be a vacuum conduit and the multi-lumen connector may further include an irrigation conduit. Each of the vacuum and irrigation conduits may be positioned within the outer conduit. The vacuum conduit may be coupled to the first single-lumen connector of the vent and the irrigation conduit may be coupled to the second single-lumen connector of the vent. The vent further may include a housing coupled to the multi-lumen connector and a filter within the housing. The filter may be in communication with the surrounding atmosphere and with the opening through a passageway of the housing.

The stopcock may include a body coupled to the vacuum and irrigation connectors and a diverter received within an aperture of the body. Each of the first and second portions of the vacuum and irrigation connectors may communicate with the aperture of the body. The vacuum connector may illustratively lie in a first horizontal plane and the irrigation connector may illustratively lie in a second horizontal plane.

The diverter may include a first cut-out portion for communication with the vacuum connector and a second cut-out portion for communication with the irrigation connector. The diverter may rotate relative to the body to connect the first and second portions of the vacuum connector with each other and to connect the first and second portions of the irrigation connector with each other to selectively communicate the vacuum source and the irrigation source to the wound.

Other features of the invention will become apparent to those skilled in the art upon consideration of the following detailed description of the preferred embodiments exemplifying the best mode of carrying out the invention as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figures in which:

<figref idref="DRAWINGS">FIGS. 1-8</figref> illustrate components of a wound care bandage system of the present disclosure which provides suction, irrigation, and ventilation to a wound;

<figref idref="DRAWINGS">FIG. 1</figref> is a part perspective, part diagrammatic view of the wound care bandage system located on the leg of a patient and coupled to a vent and to vacuum and irrigation sources through the use of a stopcock or a switch valve;

<figref idref="DRAWINGS">FIG. 2</figref> is a perspective view of the vent of the system showing a multi-lumen connector for communication with the wound via a multi-lumen tube, a single-lumen connector for communication with the switch valve, and a circular housing holding a filter (in phantom) in communication with the surrounding atmosphere;

<figref idref="DRAWINGS">FIG. 3</figref> is a side view of the vent, with portions broken away, showing the multi-lumen connector aligned for coupling to the multi-lumen tube, the single-lumen connector aligned for coupling to a single lumen tube, a passageway of the vent extending between outer lumens of the multi-lumen tube and the filter of the vent, and further showing a thin, flexible wound dressing member of the bandage coupled to the multi-lumen tube by a barbed coupler;

<figref idref="DRAWINGS">FIG. 4</figref> is a sectional view of the multi-lumen tube taken along line <b>4</b>-<b>4</b> of <figref idref="DRAWINGS">FIG. 3</figref> showing an inner lumen of the tube for communication with the vacuum source and the irrigation source of the system and four outer lumens of the tube for communication with the filter and surrounding atmosphere to aspirate an area above the wound;

<figref idref="DRAWINGS">FIG. 5</figref> is an exploded perspective view of the switch valve and vent of the system showing a vent connector of the valve aligned for coupling to the single-lumen connector of the vent, a vacuum connector for communication with the vacuum source, an irrigation connector for communication with the irrigation source, and a handle or diverter for providing selective communication between the vent connector and either the vacuum source or the irrigation source;

<figref idref="DRAWINGS">FIGS. 6</figref><i>a </i>and <b>6</b><i>b </i>are perspective views of the handle of the switch valve showing a grip and a stem of the handle and further showing a cut-out portion of the stem for selective communication between the vent, vacuum, and irrigation connectors of the switch valve;

<figref idref="DRAWINGS">FIG. 7</figref> is a sectional view taken along line <b>7</b>-<b>7</b> of <figref idref="DRAWINGS">FIG. 5</figref> showing the handle of the switch valve in an irrigation position so that the cut-out portion provides a passageway between the irrigation connector and the vent connector to permit fluid from the irrigation source to run through the switch valve to the wound;

<figref idref="DRAWINGS">FIG. 8</figref> is a sectional view similar to <figref idref="DRAWINGS">FIG. 7</figref> showing the handle of the switch valve in a vacuum position so that the cut-out portion provides a passageway between the vacuum connector and the vent connector to permit the vacuum source to draw fluid and exudate from the wound;

<figref idref="DRAWINGS">FIGS. 9-16</figref> illustrate components of another wound care bandage system in accordance with the present disclosure which also provides suction, irrigation, and ventilation to the wound;

<figref idref="DRAWINGS">FIG. 9</figref> is a part perspective, part diagrammatic view similar to <figref idref="DRAWINGS">FIG. 1</figref> showing the wound care bandage system of <figref idref="DRAWINGS">FIGS. 9-16</figref> including a two-level stopcock or switch valve in selective communication with the bandage, vacuum source, and irrigation source of the system, and further showing the two-level stopcock including a vent coupled to a filter;

<figref idref="DRAWINGS">FIG. 10</figref> is an exploded view of the two-level stopcock showing an inner barrel or handle and an outer shell, with portions broken away, and further showing the inner barrel having a grip and a stem including an upper level of ports for communication with either the vacuum source or the irrigation source, depending on the position of the inner barrel relative to the outer shell, and a lower level of ports for communication with the vent, and further showing an inner vent groove of the outer shell for providing communication between the outer lumens of the multi-lumen tube and the lower level ports of the barrel;

<figref idref="DRAWINGS">FIGS. 11-16</figref> show three positions of the two-level stopcock provided by moving the inner barrel relative to the outer shell to selectively align certain upper level ports of the inner barrel with the vacuum and irrigation connectors of the outer shell and to selectively align certain lower level ports with the vent of the outer shell;

<figref idref="DRAWINGS">FIGS. 11 and 12</figref> show the two-level stopcock in a vented vacuum position so that the vacuum source and vent are in communication with the wound to create a negative pressure adjacent the wound while drawing air into the system through the vent and over the wound to aspirate the passageways of the system;

<figref idref="DRAWINGS">FIG. 11</figref> is a top view of the two-level stopcock in the vented vacuum position showing a passageway (in phantom) connecting the vacuum connector and the multi-lumen tube connector;

<figref idref="DRAWINGS">FIG. 12</figref> is a sectional view taken along line <b>13</b>-<b>13</b> of <figref idref="DRAWINGS">FIG. 9</figref> when the two-level stopcock is in the vented vacuum position showing venting passageways of the inner barrel and showing one passageway connecting the vent groove of the outer shell with the vent;

<figref idref="DRAWINGS">FIGS. 13 and 14</figref> show the two-level stopcock in a vacuum position where only the vacuum source is in communication with the wound to create a negative pressure adjacent the wound;

<figref idref="DRAWINGS">FIG. 13</figref> is a top view similar to <figref idref="DRAWINGS">FIG. 11</figref> of the stopcock in the vacuum position after the handle has been turned clockwise from the vented vacuum position shown in <figref idref="DRAWINGS">FIG. 11</figref>, and showing a passageway (in phantom) between the vacuum connector and the multi-lumen tube connector;

<figref idref="DRAWINGS">FIG. 14</figref> is a sectional view similar to <figref idref="DRAWINGS">FIG. 12</figref> showing the two-level stopcock in the vacuum position where none of the venting passageways of the inner barrel connect the vent groove of the outer shell with the vent;

<figref idref="DRAWINGS">FIGS. 15 and 16</figref> show the two-level stopcock in a vented irrigation position where the irrigation source and the vent are in communication with the wound;

<figref idref="DRAWINGS">FIG. 15</figref> is a top view similar to <figref idref="DRAWINGS">FIGS. 11 and 13</figref> showing the two-level stopcock in the vented irrigation position after the handle has been turned clockwise from the vacuum position shown in <figref idref="DRAWINGS">FIG. 13</figref>, and showing a passageway (in phantom) between the irrigation connector and the multi-lumen connector;

<figref idref="DRAWINGS">FIG. 16</figref> is a sectional view similar to <figref idref="DRAWINGS">FIGS. 12 and 14</figref> showing the two-level stopcock in the vented irrigation position and showing a passageway of the inner barrel connecting the vent groove of the outer shell with the vent;

<figref idref="DRAWINGS">FIGS. 17-19</figref> show a multi-lumen tube coupler according to the present disclosure for use with either of the systems illustrated in <figref idref="DRAWINGS">FIGS. 1-8</figref> and <figref idref="DRAWINGS">FIGS. 9-16</figref> described above for coupling two multi-lumen tubes together;

<figref idref="DRAWINGS">FIG. 17</figref> is a part perspective, part diagrammatic view of the multi-lumen tube coupler in use with the system shown in <figref idref="DRAWINGS">FIGS. 9-16</figref>;

<figref idref="DRAWINGS">FIG. 18</figref> is a perspective view of the multi-lumen tube coupler showing an inner passageway for communication with each inner lumen of the multi-lumen tubes and an outer passageway for communication with each outer lumen of the multi-lumen tubes, and also showing a contoured upper surface and a flat bottom surface of the tube coupler;

<figref idref="DRAWINGS">FIG. 19</figref> is a sectional view of the multi-lumen tube coupler coupled to two multi-lumen tubes showing a flow path of fluids through the multi-lumen tubes and the coupler;

<figref idref="DRAWINGS">FIGS. 20-28</figref> illustrate components of yet another wound care bandage system in accordance with the present disclosure for providing suction, irrigation, and ventilation to the wound;

<figref idref="DRAWINGS">FIG. 20</figref> is a part perspective, part diagrammatic view similar to <figref idref="DRAWINGS">FIG. 1</figref> showing the wound care bandage system of <figref idref="DRAWINGS">FIGS. 20-28</figref> including a vent coupled to the bandage via a multi-lumen tube (shown in <figref idref="DRAWINGS">FIG. 21</figref>) and a stopcock or switch valve coupled to the vent (via two single-lumen tubes) to provide selective communication between the bandage and the irrigation and vacuum sources;

<figref idref="DRAWINGS">FIG. 21</figref> is an end view of the multi-lumen tube of the system shown in <figref idref="DRAWINGS">FIGS. 20-28</figref> showing the tube including a vacuum lumen, an irrigation lumen, and four outer vent lumens formed within a body of the tube;

<figref idref="DRAWINGS">FIG. 22</figref> is a perspective view of a “Y-connecter” of the system shown in <figref idref="DRAWINGS">FIGS. 20-28</figref> for coupling the wound dressing member of the bandage with the multi-lumen tube shown in <figref idref="DRAWINGS">FIG. 21</figref> showing a bandage portion of the connector for insertion within a connector of the member, a vacuum portion for insertion within the vacuum lumen of the multi-lumen tube, and an irrigation portion for insertion within the irrigation lumen of the multi-lumen tube;

<figref idref="DRAWINGS">FIG. 23</figref> is a perspective view of the vent of the system shown in <figref idref="DRAWINGS">FIG. 20</figref> showing a multi-lumen connector for coupling with the multi-lumen tube of <figref idref="DRAWINGS">FIG. 21</figref>, a vacuum connector for communication with the vacuum source via a single-lumen tube, an irrigation connector for communication with the irrigation source via a separate single-lumen tube, and also showing a filter housing coupled to the multi-lumen connector for communication with the venting lumens of the multi-lumen tube and with the atmosphere;

<figref idref="DRAWINGS">FIG. 24</figref> is a sectional view of the vent coupled to the multi-lumen tube and the two single-lumen tubes showing a filter of the vent (in phantom), the separate vacuum, irrigation, and vent passageways formed through the vent, and also showing the Y-connecter of the system coupled to the multi-lumen tube and to the member;

<figref idref="DRAWINGS">FIG. 25</figref> is an exploded perspective view of the stopcock or switch valve of the system shown in <figref idref="DRAWINGS">FIGS. 20-28</figref> showing two separate passageways through a body of the stopcock for separate communication with the vacuum source and the irrigation source, and showing a handle or diverter, having two cut-out portions, to be received within the body of the stopcock;

<figref idref="DRAWINGS">FIGS. 26-28</figref> are sectional views showing the stopcock in an irrigation position, a vacuum position, and an off position;

<figref idref="DRAWINGS">FIG. 26</figref> is a sectional view of the stopcock showing the stopcock in the vacuum position so that a first cut-out portion of the handle creates a passageway between first and second portions of a vacuum conduit of the stopcock;

<figref idref="DRAWINGS">FIG. 27</figref> is a sectional view similar to <figref idref="DRAWINGS">FIG. 26</figref> showing the stopcock in the irrigation position where the handle has been rotated in a clockwise direction from that shown in <figref idref="DRAWINGS">FIG. 26</figref> so that a second cut-out portion (shown in phantom) connects first and second portions of an irrigation conduit with each other;

<figref idref="DRAWINGS">FIG. 28</figref> is a sectional view similar to <figref idref="DRAWINGS">FIGS. 26 and 27</figref> showing the stopcock in the off position where the handle has been rotated 180 degrees from that shown in <figref idref="DRAWINGS">FIG. 27</figref> so that neither the first nor the second cut-out portions connect the first and second portions of either of the vacuum conduit or the irrigation conduit;

<figref idref="DRAWINGS">FIGS. 29-31</figref> illustrate components of still another vacuum bandage system of the present disclosure which provides suction, irrigation, and ventilation to a wound;

<figref idref="DRAWINGS">FIG. 29</figref> is a part perspective and part diagrammatic view of a vacuum bandage system of the present disclosure showing a wound dressing member of the bandage including a cover having a port and a wound contacting layer having a wound contacting surface and channels formed in an opposite surface to cooperate with the cover and form passageways of the member in communication with the port and a vacuum source and/or an irrigation source, and also showing a vent line or tube having a first end for communication with the passageways and a second end in communication with the surrounding atmosphere through a filter and a cap;

<figref idref="DRAWINGS">FIG. 30</figref> is a sectional view of the bandage of <figref idref="DRAWINGS">FIG. 29</figref> positioned within a wound and showing a sealing film of the bandage providing a sealed vacuum space above the wound, the first end of the vent line in communication with the vacuum space, and the second end of the vent line coupled to the filter and to the cap outside of the vacuum space;

<figref idref="DRAWINGS">FIG. 31</figref> is a sectional view taken along line <b>31</b>-<b>31</b> of <figref idref="DRAWINGS">FIG. 30</figref> showing the vent line and a vacuum tube coupled to each other by a coupler;

<figref idref="DRAWINGS">FIG. 32</figref> is a sectional view of an alternative vent line and vacuum tube showing a multi-lumen tube having a vent passageway and a vacuum tube passageway formed therein and separated by a partition; and

<figref idref="DRAWINGS">FIG. 33</figref> is a sectional view of yet another vent line and vacuum tube combination showing an outer wall of the vent line and an outer wall of the vacuum tube integrally coupled to one another to form a single multi-lumen tube.

DETAILED DESCRIPTION OF THE DRAWINGS

A wound care bandage system is provided which has the capability to create negative pressure adjacent the wound, to irrigate the wound, and to ventilate the wound. A vent of the system is provided to communicate with the wound and with the surrounding atmosphere. In some embodiments, a vent-valve apparatus or a vent and valve combination of the system is in communication with the wound and with a vacuum source and an irrigation source of the wound. The vent-valve apparatus includes the vent which is in communication with the surrounding atmosphere and a diverter to provide selective communication between the wound and the irrigation source or between the wound and the vacuum source, as is described in greater detail below.

One embodiment of a wound care bandage system <b>10</b> is shown in <figref idref="DRAWINGS">FIGS. 1-8</figref> and is provided to allow a caregiver to create a negative pressure above a wound surface (not shown) of a wound <b>200</b> (see <figref idref="DRAWINGS">FIG. 20</figref>) through the use of an illustrative vacuum bandage <b>14</b> and a vacuum source <b>16</b>, as shown in <figref idref="DRAWINGS">FIG. 1</figref>. System <b>10</b> further allows a caregiver to irrigate the wound surface through the use of an irrigation source <b>18</b>. Additionally, system <b>10</b> ventilates the wound during the application of negative pressure to the wound and irrigation of the wound through use of a vent <b>19</b> in communication with the surrounding atmosphere.

The system <b>10</b> further includes a stopcock or switch valve <b>50</b> coupled to vent <b>19</b>. Switch valve <b>50</b> allows a caregiver to selectively provide communication between the wound and either vacuum source <b>16</b> or irrigation source <b>18</b>. As is herein defined, the terms switch valve and stopcock are used interchangeably to describe an apparatus for selectively controlling and/or diverting fluid flow therethrough. As shown in <figref idref="DRAWINGS">FIG. 1</figref>, switch valve <b>50</b> is coupled to vent <b>19</b> via a single-lumen tube <b>52</b>. However, switch valve <b>50</b> may also be coupled directly to vent <b>19</b>, as shown in <figref idref="DRAWINGS">FIG. 5</figref> and described in more detail below. The vent <b>19</b> and switch valve <b>50</b> (and tube <b>52</b>, if used) cooperate to create a vent-valve assembly <b>80</b> to allow a caregiver to toggle between different modes such as vented vacuum therapy and vented irrigation therapy. The system <b>10</b> incorporates two separate fluid lines. One fluid line selectively provides vacuum suction or irrigation to the wound while the other fluid line vents the system <b>10</b> by providing communication between the wound and the surrounding atmosphere to create air flow above the wound.

Vacuum bandage <b>14</b>, as shown in <figref idref="DRAWINGS">FIG. 1</figref>, is provided for use with the wound and is sealed about the wound by a cover or sealing film <b>13</b> of bandage <b>14</b> to create a sealed environment between the wound and sealing film <b>13</b> in which a negative pressure can be established. Bandage <b>14</b> is selectively coupled to both vacuum source <b>16</b> and irrigation source <b>18</b> through the use of switch valve <b>50</b>, as is described in more detail below.

Bandage <b>14</b> promotes the healing of the wound by providing vacuum therapy to the wound to promote blood flow and remove exudate from the wound surface and by providing for irrigation of the wound with fluids such as saline, for example. An illustrative wound treatment apparatus having a wound temperature control system, a medicine delivery system, and a drainage system is disclosed in U.S. Pat. No. 6,458,109. An illustrative vacuum and irrigation system is disclosed in U.S. Patent Publication No. US 2002/0161317 A1. Additionally, an illustrative vacuum bandage is disclosed in U.S. Patent Publication No. US 2002/0065494 A1. Alternative vacuum bandages are disclosed in U.S. Patent Publication No. US 2002/0082567 A1. Further, a vacuum bandage system including a controller of the system is disclosed in U.S. Patent Publication No. US 2002/0198504 A1 and in U.S. Patent Publication No. US 2002/0198503 A1. All of these applications are hereby incorporated herein by reference.

As mentioned above, system <b>10</b> incorporates two separate fluid lines to provide vented vacuum therapy and vented irrigation therapy to the wound. Venting of bandage <b>14</b> is disclosed in U.S. Patent Application Ser. No. 60/344,588 filed on Dec. 26, 2001. This application is hereby incorporated herein by reference. Venting provides for increased air flow through bandage <b>14</b> and above or adjacent the wound while vacuum source <b>16</b> applies suction to the wound. System <b>10</b> is also vented while irrigation source <b>18</b> provides fluid to the wound. Without providing for ventilation of the system <b>10</b> during operation of vacuum source <b>16</b>, a generally closed system is created between vacuum bandage <b>14</b> and vacuum source <b>16</b>. For example, in bandages without a ventilation system, once the requisite amount of air has been removed by the vacuum source <b>16</b> to create a predetermined negative pressure at the wound surface, it is possible for the system to become generally static, inhibiting much, if any, fluid flow from the wound surface. In some embodiments disclosed herein, static conditions may be created at the wound surface.

Ventilation of the system <b>10</b>, while drawing a negative pressure over the wound, acts to prevent the system <b>10</b> from becoming static by drawing air in from the surrounding atmosphere through vent <b>19</b>, to bandage <b>14</b> to create air flow above the wound, and out through a vacuum tube in communication with vacuum source <b>14</b>. Therefore, venting the system <b>10</b> increases air flow above the wound while vacuum source <b>16</b> applies suction to the wound.

The two fluid lines for ventilation and vacuum/irrigation of the wound are provided in multi-lumen tube <b>20</b>, shown in cross-section in <figref idref="DRAWINGS">FIG. 4</figref>. As shown in <figref idref="DRAWINGS">FIG. 3</figref>, tube <b>20</b> is coupled to a connector <b>15</b> of bandage <b>14</b>, and is therefore in communication with the wound at one end <b>21</b> and is coupled to vent <b>19</b> at the other end <b>23</b>. Tube <b>20</b> includes an inner lumen <b>22</b> for selective communication with the vacuum source <b>16</b> and the irrigation source <b>18</b> and outer lumens <b>24</b> formed in a body or outer wall <b>25</b> of tube <b>20</b> for communication with the surrounding atmosphere through vent <b>19</b>. Inner lumen <b>22</b> thus defines a portion of a vacuum/irrigation passageway <b>42</b> and outer lumens <b>24</b> each define a portion of a ventilation passageway <b>44</b>.

As shown in <figref idref="DRAWINGS">FIG. 4</figref>, tube <b>20</b> includes four outer lumens <b>24</b> spaced about inner lumen <b>22</b>. It is within the scope of this disclosure, however, to include a multi-lumen tube having one or more outer lumens in communication with the surrounding atmosphere and one or more inner lumens in selective communication with the vacuum source <b>16</b> and the irrigation source <b>18</b>. Illustratively, the outer diameter <b>26</b> of tube <b>20</b> is 0.250 inch (6.300 mm), the inner diameter <b>28</b> of tube <b>20</b> (the diameter of inner lumen <b>22</b>) is 0.125 inch (3.150 mm), and the diameter <b>29</b> of each outer or peripheral lumen is 0.014 inch (0.353 mm). Although tube <b>20</b> includes the above dimensions, it is within the scope of this disclosure to provide any suitable multi-lumen tube having lumens of any suitable size.

As shown in <figref idref="DRAWINGS">FIG. 3</figref>, bandage <b>14</b> illustratively includes a thin, flexible wound dressing member <b>12</b> having connector <b>15</b> coupled to tube <b>20</b> by a barbed tube coupler <b>11</b>. Member <b>12</b> lies adjacent to and generally conforms to the wound surface. Sealing film <b>13</b> is placed over member <b>12</b> and sealed around tube <b>20</b> to the patient's healthy skin <b>27</b> surrounding the wound, as shown in <figref idref="DRAWINGS">FIG. 1</figref>. Illustratively, connector <b>15</b> is in communication with the wound by a plurality of passageways <b>66</b> of member <b>12</b> and a plurality of holes <b>67</b>, each in communication with one of the passageways <b>66</b>, formed in a bottom surface <b>68</b> of member <b>19</b>. Tube coupler <b>11</b> connects inner lumen <b>22</b> of tube <b>20</b> with connector <b>15</b>. Each outer lumen <b>24</b> is open at an end <b>21</b> of tube <b>20</b>. This allows air to be drawn in from the atmosphere through vent <b>19</b>, to flow through outer lumens <b>24</b> and exit tube <b>20</b> at end <b>21</b>, to circulate around member <b>12</b> to the wound surface, and to flow through the holes <b>67</b> and passageways <b>66</b> of member <b>12</b> into a vacuum/irrigation passageway <b>42</b> formed in part by lumen <b>22</b>. The negative pressure created by vacuum source <b>16</b> causes air to flow through system <b>10</b> in this manner.

Although bandage <b>14</b> is described above, it is within the scope of this disclosure for the system <b>10</b>, and other alternative systems described below, to include any suitable bandage or wound dressing member coupled to the vacuum source <b>16</b> to communicate negative pressure from the vacuum source <b>16</b> to the wound. Bandage <b>14</b>, therefore, is merely an illustrative bandage of the wound care bandage systems disclosed herein.

As mentioned above, system <b>10</b> further includes vent <b>19</b>. Vent <b>19</b> is coupled to end <b>23</b> of tube <b>20</b>, as shown in <figref idref="DRAWINGS">FIG. 1</figref>, and is illustratively shown to be coupled to patient's healthy skin <b>27</b> by tape <b>94</b>, for example. As shown in <figref idref="DRAWINGS">FIGS. 2 and 3</figref>, vent <b>19</b> includes a multi-lumen or wound connector <b>30</b> for coupling with multi-lumen tube <b>20</b> and a single-lumen connector <b>32</b> for coupling with single-lumen tube <b>52</b> or for coupling directly to switch valve <b>50</b>, as shown in <figref idref="DRAWINGS">FIG. 5</figref>. Vent <b>19</b> further includes a filter <b>34</b>, shown in phantom in <figref idref="DRAWINGS">FIGS. 2 and 3</figref>, housed within a filter housing <b>40</b>. Multi-lumen connector <b>30</b> includes an inner conduit <b>36</b> and an outer conduit <b>38</b> concentric and coaxial with inner conduit <b>36</b> along an axis <b>39</b>, as shown in <figref idref="DRAWINGS">FIG. 3</figref>. An edge <b>41</b> of inner conduit <b>36</b> is substantially coplanar with an edge <b>43</b> of outer conduit <b>38</b>. An annular space <b>45</b> is defined between a cylindrical inner surface <b>47</b> of outer conduit <b>38</b> and a cylindrical outer surface <b>53</b> of inner conduit <b>36</b>.

Inner conduit <b>36</b> is in communication with vacuum source <b>16</b> and irrigation source <b>18</b> through stopcock <b>50</b> and defines a portion of the vacuum/irrigation passageway <b>42</b>. The vacuum/irrigation passageway <b>42</b> extends through inner lumen <b>22</b>, a portion of vent <b>19</b> and stopcock <b>50</b>. Outer conduit <b>38</b>, or annular space <b>45</b>, is in communication with the surrounding atmosphere and defines a portion of vent passageway <b>44</b>. The vent passageway <b>44</b> extends through outer lumens <b>24</b> and a portion of vent <b>19</b> to the surrounding atmosphere.

As shown in <figref idref="DRAWINGS">FIG. 3</figref>, a ridge or stop <b>59</b> is coupled to inner surface <b>47</b> of outer conduit <b>38</b> to prevent tube <b>20</b> from being inserted too far within connector <b>30</b> and thus sealing off outer lumens <b>24</b>. Stop <b>59</b> prevents vent passageway <b>44</b> from becoming closed off and keeps vent passageway <b>44</b> open to receive air from the surrounding atmosphere. Vent <b>19</b> includes three evenly spaced stops <b>59</b> coupled to inner surface <b>47</b>. It is within the scope of this disclosure, however, to include a vent having any number of stops <b>59</b> or the like to prevent vent passageway <b>44</b> from becoming closed off.

When connecting multi-lumen tube <b>20</b> with vent <b>19</b>, inner conduit <b>36</b> is received within inner lumen <b>22</b> of tube <b>20</b>. Wall <b>25</b> of tube <b>20</b>, which includes outer lumens <b>24</b>, is received within annular space <b>45</b> of connecter <b>30</b>. Tube <b>20</b> is, therefore, press fit into connector <b>30</b> and, if desired, may be permanently coupled to connecter <b>30</b> through the use of adhesives applied to the appropriate surfaces of connecter <b>30</b> and/or tube <b>20</b>.

Connector <b>32</b> is received within single-lumen tube <b>52</b> when connecting vent <b>19</b> to tube <b>52</b>. Tube <b>52</b> is press fit onto connector <b>32</b> so that an end <b>65</b> of single-lumen tube <b>52</b> abuts an annular shoulder surface <b>69</b> of conduit <b>30</b>. As noted above, vent <b>19</b> may also be coupled directly to switch valve <b>50</b> through the use of a luer lock connection shown in <figref idref="DRAWINGS">FIG. 5</figref> and discussed further below.

As shown in <figref idref="DRAWINGS">FIG. 3</figref>, vent <b>19</b> includes an opening or passageway <b>46</b> leading between outer conduit <b>38</b> and filter <b>34</b> to connect annular space <b>45</b> with the surrounding atmosphere. Opening <b>46</b> extends radially away from conduit <b>30</b> and is generally perpendicular to axis <b>39</b>. Opening <b>46</b> is defined by cylindrical wall <b>27</b>. Illustratively, opening <b>46</b> has a diameter of 0.100 inch (2.54 mm), however, it is within the scope of this disclosure to include a vent having any suitably sized opening for receiving air from the surrounding atmosphere.

Further illustratively, filter <b>34</b>, is a 0.2 micron anti-microbial filter for preventing bacteria and other microorganisms in the atmosphere from entering the vent <b>19</b> and traveling along vent passageway <b>44</b> below sealing film <b>13</b> of bandage <b>14</b> to the wound. Such an air filter, for example, is made by W.L. Gore &amp; Associates, Inc. of Elkton, Md. As mentioned above, filter <b>34</b> is housed within housing <b>40</b>. Housing <b>40</b> has a circular top wall <b>31</b>, a cylindrical sidewall <b>33</b>, and a circular bottom wall (not shown). Filter <b>34</b> is a generally circular dish of material sandwiched between top wall <b>31</b> and the bottom wall. The bottom wall has apertures, openings, or the like so that filter <b>34</b> is in communication with the surrounding atmosphere. Further, the bottom wall is removable so that filter <b>34</b> may be replaced if needed. Vent <b>19</b> further includes reinforcement ribs <b>35</b> appended to top wall <b>31</b> of housing <b>40</b> and wall <b>27</b> defining passageway <b>46</b>.

In operation, vent <b>19</b> is used during both vacuum and irrigation modes of the system. As mentioned before, vent <b>19</b> provides increased air flow through bandage <b>14</b> and above the wound. Vent <b>19</b> also creates an open system and prevents the system from becoming static. The air flow path while vacuuming the system begins as air is drawn in from the surrounding atmosphere into filter housing <b>40</b> of vent <b>19</b> and through filter <b>34</b>. The air then travels through opening <b>46</b> into annular space <b>45</b> defined by outer conduit <b>38</b> and through outer lumens <b>24</b> of multi-lumen tube <b>20</b>. The air travels through the outer lumens <b>24</b> from vent end <b>23</b> of tube <b>20</b> to end <b>21</b> of tube <b>20</b>, a portion of which is positioned under sealing film <b>13</b>, to communicate with the wound. Vacuum source <b>16</b> then draws the air around wound dressing member <b>12</b> through passageways <b>66</b> at an open peripheral edge of member <b>12</b> and through holes <b>67</b> into passageways <b>66</b>. Air is then drawn from passageways <b>66</b> into connector <b>15</b> of member <b>12</b>, through barb <b>11</b>, and through inner lumen <b>22</b> of multi-lumen tube <b>20</b> toward vacuum source <b>14</b>.

It is also within the scope of the disclosure for the caregiver to close off vent <b>19</b> while vacuuming or irrigating the wound. Vent <b>19</b> may be closed in a number of ways. For example, a cap or valve (not shown) may be coupled to filter <b>34</b> or filter housing <b>40</b> to prevent air flow through filter <b>40</b>. It is within the scope of this disclosure to include a vent having other suitable means of preventing air flow therethrough.

As shown in <figref idref="DRAWINGS">FIG. 3</figref> and mentioned above, inner conduit <b>36</b> and outer conduit <b>38</b> form separate passageways through vent <b>19</b>. Inner conduit <b>36</b> is in communication with and forms a portion of vacuum/irrigation passageway <b>42</b> which extends through inner lumen <b>22</b>, a portion of vent <b>19</b> and on to switch valve <b>50</b>. Outer conduit <b>38</b> is in communication with and forms a portion of vent passageway <b>44</b>, which extends through outer lumens <b>24</b> and a portion of vent <b>19</b>. Vent passageway <b>44</b> is in communication with the atmosphere through filter <b>34</b>.

As shown in <figref idref="DRAWINGS">FIG. 1</figref>, system <b>10</b> further includes switch valve <b>50</b>. Switch valve <b>50</b> is positioned between vent <b>19</b> and vacuum and irrigation sources <b>16</b>, <b>18</b>. Single-lumen tube <b>52</b> is coupled to and extends between single-lumen connector <b>32</b> of vent <b>19</b> and switch valve <b>50</b> and forms a portion of vacuum/irrigation passageway <b>42</b>. Switch valve <b>50</b>, includes a vent connector <b>54</b> which can be coupled either to single-lumen tube <b>52</b>, as shown in <figref idref="DRAWINGS">FIG. 1</figref>, or directly to connecter <b>32</b> of vent <b>19</b>, as shown in <figref idref="DRAWINGS">FIG. 5</figref>, through the use of a luer lock. Single-lumen connector <b>32</b> includes a female thread portion <b>55</b> of the luer lock, and vent connector <b>54</b> of switch valve <b>50</b> includes a male portion <b>57</b> of the luer lock so that the two can be coupled together.

As shown in <figref idref="DRAWINGS">FIG. 5</figref>, switch valve <b>50</b> includes a body <b>60</b> and a handle or diverter <b>51</b> coupled to body <b>60</b>. Body <b>60</b> includes vent connector <b>54</b>, a vacuum connector <b>56</b> in communication with vacuum source <b>16</b>, and an irrigation connector <b>58</b> in communication with irrigation source <b>18</b>. Vent connector <b>54</b> forms another portion of vacuum/irrigation passageway <b>42</b> and is in selective communication with vacuum source <b>16</b> and irrigation source <b>18</b>. Vacuum/irrigation passageway <b>42</b> therefore extends from end <b>21</b> of inner lumen <b>22</b> of multi-lumen tube <b>20</b> to multi-lumen connector <b>30</b> of vent <b>19</b>, through inner conduit <b>36</b> of vent <b>19</b>, out connector <b>32</b> of vent <b>19</b>, to vent connector <b>54</b> of switch valve <b>50</b> and partially through switch valve <b>50</b> to diverter <b>51</b> of switch valve <b>50</b>.

Switch valve <b>50</b> includes diverter <b>51</b> for selectively providing communication between vacuum source <b>16</b> and bandage <b>14</b> and between irrigation source <b>18</b> and bandage <b>14</b>. Diverter <b>51</b> includes a grip <b>62</b> and a stem <b>64</b> coupled to grip <b>62</b>, as show in <figref idref="DRAWINGS">FIGS. 6</figref><i>a </i>and <b>6</b><i>b</i>. Diverter <b>51</b> is rotatably movable relative to body <b>60</b> to selectively provide communication between either vent connector <b>54</b> and irrigation connector <b>58</b> or between vent connector <b>54</b> and vacuum connector <b>56</b>. A caregiver rotates diverter <b>51</b> between an irrigation position shown in <figref idref="DRAWINGS">FIG. 7</figref> and a vacuum position shown in <figref idref="DRAWINGS">FIG. 8</figref> depending on whether the wound is to receive vacuum or irrigation treatment, respectively. Switch valve <b>50</b> allows the caregiver to easily switch between communication with vacuum source <b>16</b> and irrigation source <b>18</b> without the need to disconnect or reconnect various tubes from each of the vacuum source <b>16</b> and/or irrigation source <b>18</b>, for example.

As shown in <figref idref="DRAWINGS">FIGS. 7 and 8</figref>, body <b>60</b> includes an aperture <b>61</b> for receiving stern <b>64</b> of diverter <b>51</b>. Vent connector <b>54</b>, vacuum connector <b>56</b>, and irrigation connector <b>58</b> each form a respective opening <b>82</b>, <b>84</b>, <b>86</b> in communication with aperture <b>61</b>. As diverter <b>51</b> is rotated, a cut-out portion <b>63</b> of stem <b>64</b> provides a passageway between vent connector <b>54</b> and vacuum connector <b>56</b> when diverter <b>51</b> is in the vacuum position, for example. When diverter <b>51</b> is in the irrigation position, cut-out portion <b>63</b> provides a passageway between vent connector <b>54</b> and irrigation connector <b>58</b>. Diverter <b>51</b> is also movable to an off position where cut-out portion <b>63</b> does not provide any communication between the connectors <b>54</b>, <b>56</b>, <b>58</b>.

In addition to vacuum/irrigation passageway <b>42</b> and vent passageway <b>44</b>, system <b>10</b> further includes a separate vacuum passageway <b>70</b> and a separate irrigation passageway <b>72</b>. Vacuum connector <b>56</b> defines a portion of vacuum passageway <b>70</b> and irrigation connector <b>58</b> defines a portion of irrigation passageway <b>72</b>. As shown in <figref idref="DRAWINGS">FIG. 1</figref>, vacuum connector <b>56</b> is coupled to a vacuum tube <b>74</b> which is, in turn, coupled to vacuum source <b>16</b>. The vacuum passageway <b>70</b>, therefore, extends from opening <b>84</b> of body <b>60</b> through vacuum connector <b>56</b> and vacuum tube <b>74</b> to vacuum source <b>16</b>.

As shown in <figref idref="DRAWINGS">FIG. 1</figref>, irrigation connector <b>58</b> is coupled to an irrigation tube <b>76</b> which is, in turn, coupled to irrigation source <b>18</b>. The irrigation passageway <b>72</b>, therefore, extends from opening <b>86</b> of body <b>60</b> through irrigation connector <b>58</b> and irrigation tube <b>76</b> to irrigation source <b>18</b>. Thus, at opening <b>82</b> of body <b>60</b>, vacuum/irrigation passageway <b>42</b> ends and is split into separate vacuum and irrigation passageways <b>70</b>, <b>72</b>.

As shown in <figref idref="DRAWINGS">FIG. 5</figref>, an attachment <b>88</b> is coupled to irrigation connector <b>58</b>. Attachment <b>88</b> includes a first inlet <b>90</b> for communication with irrigation tube <b>76</b> and irrigation source <b>18</b> and a second inlet <b>92</b> for communication with a hand-held syringe (not shown). Attachment <b>88</b> provides two means of introducing fluids into system <b>10</b>. Second inlet <b>92</b> allows a caregiver to manually introduce fluids into system <b>10</b> while irrigation source <b>18</b> includes automatic controls for introducing fluids into system <b>10</b> through first inlet <b>90</b>. A slot <b>96</b> of irrigation connector <b>58</b> receives a portion of second inlet <b>92</b> to secure attachment <b>88</b> within irrigation connector <b>58</b>.

As mentioned above, system <b>10</b> allows a caregiver to treat the wound using vented vacuum therapy through the use of vent <b>19</b> with vacuum source <b>16</b> and using vented irrigation therapy through the use of irrigation source <b>18</b> and vent <b>19</b>. To provide vented vacuum therapy to the wound, the caregiver moves diverter <b>51</b> to the vacuum position, shown in <figref idref="DRAWINGS">FIG. 8</figref>, so that cut-out portion <b>63</b> of stem <b>64</b> connects opening <b>82</b> of vent connector <b>54</b> with opening <b>84</b> of vacuum connector <b>56</b>. Therefore, irrigation connector <b>58</b> and irrigation passageway <b>72</b> are closed off and vacuum/irrigation passageway <b>42</b> is connected with vacuum connector <b>56</b> and vacuum passageway <b>70</b>. Vent passageway <b>44</b> is kept open to the surrounding atmosphere. The negative pressure provided by vacuum source <b>16</b> above wound <b>12</b> acts to draw air in from the atmosphere through filter <b>34</b> of vent <b>19</b> and outer lumens <b>24</b>. As mentioned above, vent <b>19</b> is provided to aspirate the system <b>10</b> by creating an air flow path from the atmosphere to the bandage <b>14</b>, over the wound, and out through inner lumen <b>22</b> in communication with vacuum source <b>16</b>.

To create vented irrigation of wound <b>12</b>, a caregiver moves diverter <b>51</b> to the irrigation position so that cut-out portion <b>63</b> of stem <b>64</b> connects opening <b>82</b> of vent connector <b>54</b> with opening <b>56</b> of irrigation connector <b>58</b>. Therefore, irrigation passageway <b>72</b> of the irrigation connector <b>58</b> is in communication with the vacuum/irrigation passageway <b>42</b> of the vent connector <b>54</b>. The vacuum passageway <b>70</b> is thus cut off from communication with the vacuum/irrigation passageway <b>42</b>. Irrigation fluid is then dispensed from irrigation source <b>18</b> through irrigation passageway <b>72</b> of tube <b>76</b> and switch valve <b>50</b> to the vacuum/irrigation passageway <b>42</b> through vent connector <b>54</b>, tube <b>52</b>, vent <b>19</b>, and inner lumen <b>22</b> of multi-lumen tube <b>20</b> to wound <b>12</b>. Vent <b>19</b> is left in an open position to allow air to flow out of bandage <b>14</b> while fluid from irrigation source <b>18</b> is channeled to the wound. As mentioned above, it is also within the scope of this disclosure to provide non-vented irrigation of the wound by closing off vent <b>19</b> from the surrounding atmosphere while providing fluid to the wound through irrigation source <b>18</b>.

As mentioned above, the combination of vent <b>19</b>, and switch valve <b>50</b> is defined as vent-valve assembly <b>80</b>. If desired, assembly <b>80</b> may also include tube <b>52</b> or another conduit or passageway between vent <b>19</b> and switch valve <b>50</b>. Assembly <b>80</b> provides a caregiver with the ability to toggle or selectively switch between the vented vacuum mode of therapy and the vented irrigation mode of therapy for the treatment of the wound. As mentioned above, it is within the scope of this disclosure to include a vent which is able to be closed off from communication with the surrounding atmosphere so that vacuum only and/or irrigation only therapy may be provided as well.

An alternative vent-valve assembly <b>180</b> is provided for use with system <b>10</b>, as shown in <figref idref="DRAWINGS">FIGS. 9-16</figref>. Assembly <b>180</b> includes a stopcock or valve portion in selective communication with vacuum source <b>16</b> and irrigation source <b>18</b> and a vent portion in communication with the surrounding atmosphere. Assembly <b>180</b> is configured to selectively provide three modes of therapy: vacuum therapy, vented vacuum therapy, and vented irrigation therapy.

As shown in <figref idref="DRAWINGS">FIG. 9</figref>, vent-valve assembly <b>180</b> is positioned between illustrative bandage <b>14</b> of system <b>10</b> and vacuum and irrigation sources <b>16</b>, <b>18</b>. Assembly <b>180</b> serves a similar function as assembly <b>80</b>, including vent <b>19</b> and stopcock <b>50</b>, shown in <figref idref="DRAWINGS">FIGS. 1-8</figref>. Similar to assembly <b>80</b>, assembly <b>180</b> is in communication with bandage <b>14</b>, vacuum source <b>16</b>, and irrigation source <b>18</b> of system <b>10</b>. Assembly <b>180</b> is operated by a caregiver during the treatment of a patient to change from mode to mode as desired.

As shown in <figref idref="DRAWINGS">FIG. 10</figref>, assembly <b>180</b> includes an outer shell or body <b>110</b> and a diverter or inner barrel <b>112</b>. Inner barrel <b>112</b> is normally positioned within outer shell <b>110</b>, as shown in <figref idref="DRAWINGS">FIG. 9</figref>, and is rotatable relative to outer shell <b>110</b> between three different positions which correlate with the three available modes: vacuum, vented vacuum, vented irrigation. Outer shell <b>110</b> includes a cylindrical hub <b>114</b> having an outer surface <b>116</b> and in inner surface <b>118</b>, shown in <figref idref="DRAWINGS">FIG. 10</figref>. Outer shell <b>110</b> further includes a multi-lumen or wound connector <b>130</b>, a vent <b>119</b>, a vacuum connector <b>156</b>, and an irrigation connector <b>158</b>. Suitable coupling means such as a C-clip (not shown) to fit around inner barrel <b>112</b>, a pin (not shown) through outer shell <b>110</b> and inner barrel <b>112</b>, for example, are provided to prevent inner barrel or diverter <b>112</b> from being inadvertently separated from body <b>110</b>. Such coupling means are also provided for use with stopcocks <b>50</b> and <b>250</b> (discussed below) to prevent the handle of each from being inadvertently decoupled from the body of each.

Similar to multi-lumen connector <b>30</b> of vent <b>19</b>, multi-lumen connector <b>130</b> of assembly <b>180</b> includes inner conduit <b>36</b> and outer conduit <b>38</b> spaced apart from and concentric with inner conduit <b>36</b>. Inner conduit <b>36</b> defines a portion of vacuum/irrigation passageway <b>42</b> and outer conduit <b>38</b> defines a portion of vent passageway <b>44</b> of system <b>10</b>. Inner conduit <b>36</b> is received within inner lumen <b>22</b> of tube <b>20</b>. Wall <b>25</b> of tube <b>20</b>, which includes outer lumens <b>24</b>, is received within outer conduit <b>38</b> of multi-lumen connector <b>130</b>. As shown in <figref idref="DRAWINGS">FIG. 9</figref>, inner conduit <b>36</b> is coupled to a barb <b>37</b>. Barb <b>37</b> is received within inner lumen <b>22</b> as well and helps maintain the connection between tube <b>20</b> and multi-lumen connector <b>130</b>. It is within the scope of this disclosure for multi-lumen connector <b>30</b> of vent <b>19</b> to have barb <b>37</b> formed integrally with inner conduit <b>36</b>.

As shown in <figref idref="DRAWINGS">FIG. 10</figref>, outer conduit <b>38</b> includes a partition <b>48</b> having multiple vent holes <b>49</b> formed therethrough. Air traveling through lumens <b>24</b> also travels through the holes <b>49</b> to a vent groove <b>122</b> formed in inner surface <b>118</b> of hub <b>114</b>. It is not necessary for outer lumens <b>24</b> of tube <b>20</b> to align directly with one of the vent holes <b>49</b>. A stop (not shown), similar to stop <b>59</b>, is coupled to inner surface <b>47</b> of outer conduit <b>38</b> to prevent tube <b>20</b> from being inserted too far within connecter <b>130</b>. Vent groove <b>122</b> connects outer conduit <b>38</b> with vent <b>119</b>, as is described in more detail below.

Vacuum connector <b>156</b> communicates with vacuum source <b>16</b> through vacuum tube <b>74</b>. Vacuum connector <b>156</b> includes barb <b>37</b> received within tube <b>74</b>. Vacuum connector <b>156</b> and vacuum tube <b>74</b> form vacuum passageway <b>70</b> of system <b>10</b>. Irrigation connector <b>158</b> communicates with irrigation source <b>18</b> through irrigation tube <b>76</b>, as shown in <figref idref="DRAWINGS">FIG. 17</figref>. Irrigation connector <b>158</b> and irrigation tube <b>76</b> form the irrigation passageway <b>72</b> of system <b>10</b>. Vacuum connector <b>156</b> and irrigation connector <b>158</b> are each in selective communication with multi-lumen connector <b>130</b>, as is described below. As shown in <figref idref="DRAWINGS">FIG. 9</figref>, air filter <b>34</b>, contained within a housing <b>124</b>, is coupled to vent <b>119</b> and is received within an aperture <b>120</b> (shown in <figref idref="DRAWINGS">FIG. 10</figref>) of vent <b>119</b>. Housing <b>124</b> includes an air inlet tube <b>126</b> and a connector tube <b>128</b> coupled to vent <b>119</b> and in communication with aperture <b>120</b> of vent <b>119</b>.

Diverter <b>112</b>, as shown in <figref idref="DRAWINGS">FIG. 10</figref>, includes a grip <b>162</b> and a cylinder or stem <b>164</b> coupled to grip <b>162</b>. Cylinder <b>164</b> includes an upper level of holes and a lower level of holes, as shown in <figref idref="DRAWINGS">FIG. 10</figref>. As shown in phantom in <figref idref="DRAWINGS">FIGS. 11</figref>, <b>13</b>, and <b>15</b>, the upper level of holes includes first, second, third, fourth, and fifth holes <b>166</b>, <b>168</b>, <b>170</b>, <b>172</b>, <b>174</b>, respectively. As shown in <figref idref="DRAWINGS">FIGS. 12</figref>, <b>14</b>, and <b>16</b>, the lower level of holes includes first, second, third, and fourth holes <b>182</b>, <b>184</b>, <b>186</b>, and <b>188</b>, respectively. The upper level of holes communicate with inner conduit <b>36</b> of multi-lumen connector <b>130</b> and with each of the vacuum and irrigation connectors <b>156</b>, <b>158</b>. The lower level of holes communicate with outer conduit <b>38</b> and aperture <b>120</b> of vent <b>119</b>. The upper holes of cylinder <b>164</b> form interconnecting passageways through cylinder <b>164</b> to selectively connect inner conduit <b>36</b> with vacuum conduit <b>156</b> and irrigation conduit <b>158</b> and the lower holes form passageways through cylinder <b>164</b> to selectively connect outer conduit <b>38</b> with vent <b>119</b>, as is described in more detail below.

As shown in <figref idref="DRAWINGS">FIGS. 11 and 12</figref>, assembly <b>180</b> is in the vented vacuum position. As shown in <figref idref="DRAWINGS">FIG. 11</figref>, the upper holes are positioned so that hole <b>166</b> is in communication with inner conduit <b>36</b> and hole <b>170</b> is in communication with vacuum connector <b>156</b> to provide a passageway between inner conduit <b>36</b> and vacuum connector <b>156</b>. The other holes <b>168</b>, <b>172</b> and <b>174</b> are not in communication with any of the connectors <b>130</b>, <b>156</b>, <b>158</b> of outer shell <b>110</b>. Looking now to the lower level of holes shown in <figref idref="DRAWINGS">FIG. 12</figref>, hole <b>182</b> is in communication with vent groove <b>122</b> and hole <b>186</b> is in communication with aperture <b>120</b> of vent <b>119</b> to provide a passageway between vent groove <b>122</b> and vent <b>119</b> so that outer lumens <b>24</b> of tube <b>20</b> are in communication with the surrounding atmosphere.

By rotating grip <b>162</b> clockwise (as viewed from the top of apparatus <b>180</b>), a caregiver rotates inner barrel <b>112</b> relative to outer shell <b>110</b> to move assembly <b>180</b> to the vacuum position shown in <figref idref="DRAWINGS">FIGS. 13 and 14</figref>. In the vacuum position, upper level hole <b>174</b> is in communication with inner conduit <b>36</b> of multi-lumen connector <b>130</b> and hole <b>168</b> is in communication with vacuum connector <b>156</b> to provide a passageway between inner conduit <b>36</b> and vacuum connector <b>156</b>. In the vacuum position, however, vent passageway <b>44</b> of system <b>10</b> is prevented from communicating with the surrounding atmosphere through vent <b>119</b>. As shown in <figref idref="DRAWINGS">FIG. 14</figref>, for example, none of the lower level holes are in communication with either vent groove <b>122</b> or aperture <b>120</b> of vent <b>119</b>.

By rotating grip <b>162</b> still further clockwise, a caregiver rotates inner barrel <b>112</b> relative to outer shell <b>110</b> to move assembly <b>180</b> to the vented irrigation position shown in <figref idref="DRAWINGS">FIGS. 15 and 16</figref>. <figref idref="DRAWINGS">FIG. 15</figref> shows the orientation of the upper level holes of the inner barrel <b>112</b> while assembly <b>180</b> is in the vented irrigation position. Hole <b>172</b> is in communication with inner conduit <b>36</b> of multi-lumen connector <b>130</b> and hole <b>166</b> is in communication with irrigation connector <b>158</b> to provide communication between inner conduit <b>36</b> and irrigation connector <b>158</b>. <figref idref="DRAWINGS">FIG. 16</figref> shows the orientation of the lower level holes when stopcock <b>180</b> is in the vented irrigation position. Hole <b>188</b> is in communication with vent groove <b>122</b> and hole <b>184</b> is in communication with aperture <b>120</b> of vent <b>119</b> so that outer conduit <b>38</b> is in communication with vent <b>119</b> to allow air from the surrounding atmosphere to enter system <b>10</b>. It is also within the scope of this disclosure for assembly <b>180</b> to be in an “off” position where none of the upper level passageways connect any of the connecters <b>130</b>, <b>158</b>, <b>156</b> with each other, and where none of the lower level passageways connect the vent grove <b>122</b> with the vent <b>119</b>.

Referring now to <figref idref="DRAWINGS">FIGS. 17-19</figref>, a tube coupler <b>140</b> is provided for use with system <b>10</b>. As shown in <figref idref="DRAWINGS">FIG. 17</figref>, coupler <b>140</b> is positioned between bandage <b>14</b> and assembly <b>180</b>. It is within the scope of this disclosure, however, to position a tube coupler between bandage <b>14</b> and assembly <b>80</b> shown in <figref idref="DRAWINGS">FIG. 1</figref>. Coupler <b>140</b> connects or couples two multi-lumen tubes together. Coupler <b>140</b> allows a caregiver to disconnect a portion of system <b>10</b> between bandage <b>14</b> and assemblies <b>80</b> or <b>180</b>. As shown in <figref idref="DRAWINGS">FIGS. 17-19</figref>, coupler <b>140</b> couples multi-lumen tube <b>20</b> to another multi-lumen tube <b>17</b>.

Coupler <b>140</b> includes an outer body <b>142</b> having a curved upper surface <b>144</b> and a generally flat bottom surface <b>146</b>. Outer body <b>142</b> defines a passageway <b>148</b> therethrough for receiving a portion of a multi-lumen tube at a first end <b>136</b> and at a second end <b>138</b>. Passageway <b>148</b> is defined by an inner surface <b>149</b> of body <b>142</b>. Coupler <b>140</b> further includes an inner conduit <b>150</b> which defines a portion of vacuum/irrigation passageway <b>42</b>. Inner conduit <b>150</b> is positioned within passageway <b>148</b>. A portion of vent passageway <b>44</b> is annular and is defined between inner surface <b>149</b> of body <b>142</b> and an outer surface <b>151</b> of inner conduit <b>150</b>. Coupler <b>140</b> further includes a central partition <b>152</b> formed around conduit <b>150</b> and connected to inner surface <b>149</b>. Partition <b>152</b> includes three generally evenly spaced holes <b>154</b> for the vented air to flow through.

An end of tube <b>20</b> is inserted into first end <b>136</b> of coupler <b>140</b> and an end of tube <b>17</b> is inserted into second end <b>138</b> of coupler <b>140</b>, as shown in <figref idref="DRAWINGS">FIG. 19</figref>, so that inner conduit <b>150</b> is received within the inner lumen <b>22</b> of each tube <b>20</b>, <b>17</b>. As mentioned above, multi-lumen tubes <b>20</b>, <b>17</b> include four outer lumens <b>24</b> formed in wall <b>25</b>. As shown in <figref idref="DRAWINGS">FIG. 19</figref>, tubes <b>20</b>, <b>17</b> are inserted into coupler <b>140</b> and are generally spaced-apart from partition <b>152</b> so that air flowing through the four outer lumens <b>24</b> of tube <b>17</b> flows into an open space <b>155</b> on the right side of partition <b>152</b>, as shown in <figref idref="DRAWINGS">FIG. 19</figref>, through holes <b>154</b> of partition <b>152</b> and into an open space <b>157</b> located on the left side of partition <b>152</b> into outer lumens <b>24</b> of tube <b>20</b>.

Tube coupler <b>140</b> may also be used to aide in effectively securing sealing film <b>13</b> of bandage <b>14</b> over or around tube <b>20</b>. For example, coupler <b>140</b> may be placed on the patient's healthy skin adjacent the wound. The film <b>13</b> may then be placed over curved upper surface <b>144</b> of coupler <b>140</b> and effect a seal around coupler <b>140</b> to create a sealed environment between film <b>13</b> and the wound. Coupler <b>140</b>, therefore, may also act to prevent leaks in the vacuum space created below film <b>13</b>. Coupler <b>140</b> further includes a ridge or stop <b>153</b> coupled to inner surface <b>149</b> to each of the right and left sides of partition <b>152</b> to prevent each respective tube <b>20</b>, <b>17</b> from abutting partition <b>152</b> and closing off vent lumens <b>24</b> from communication with the surrounding atmosphere. Each open space <b>155</b>, <b>157</b>, therefore, is defined between a respective stop <b>153</b> and partition <b>152</b>, as shown in <figref idref="DRAWINGS">FIG. 19</figref>.

Referring now to <figref idref="DRAWINGS">FIGS. 20-28</figref>, another illustrative wound care bandage system <b>210</b> is provided. System <b>210</b> operates similarly to system <b>10</b> described above and includes a vent-valve apparatus <b>280</b> to provide ventilation while allowing a user to toggle between a vacuum therapy mode and an irrigation therapy mode. As shown in <figref idref="DRAWINGS">FIG. 20</figref>, bandage <b>14</b> is coupled to a vent <b>219</b> via an alternative multi-lumen tube <b>220</b>. Specifically, member <b>12</b> of bandage <b>14</b> is coupled to a “Y-connector” <b>212</b> of the system <b>210</b> which is coupled to tube <b>220</b>. Y-connector <b>212</b> is shown in more detail in <figref idref="DRAWINGS">FIGS. 22 and 24</figref> and is discussed in more detail below.

Vent-valve apparatus <b>280</b> includes a stopcock or switch valve <b>250</b> coupled to vent <b>219</b> via two single-lumen tubes <b>216</b>, <b>218</b>. Switch valve <b>250</b> is coupled to both vacuum source <b>16</b> and irrigation source <b>18</b> to provide selective communication between either the bandage <b>14</b> and vacuum source <b>16</b> or between bandage <b>14</b> and irrigation source <b>18</b>, as described below.

Vent <b>219</b>, similar to vent <b>19</b>, is spaced apart from bandage <b>14</b> and is illustratively shown to be coupled to patient's healthy skin <b>27</b> by tape <b>94</b>, for example. Vent <b>219</b> is able to provide ventilation to wound <b>200</b> (shown in <figref idref="DRAWINGS">FIG. 20</figref>) during the application of negative pressure to wound <b>200</b> and during irrigation of wound <b>200</b> because vent <b>219</b>, similar to vents <b>19</b> and <b>119</b> are in communication with the surrounding atmosphere and with the wound <b>200</b>.

The wound care bandage system <b>210</b> shown in <figref idref="DRAWINGS">FIGS. 20-28</figref> incorporates three separate fluid paths. One fluid path is used exclusively for the purpose of venting the wound <b>200</b> with air from the surrounding atmosphere. A second fluid path is used to create a negative pressure adjacent the wound <b>200</b>, while the third fluid path is used to irrigate the wound <b>200</b>. Switch valve <b>250</b> acts to selectively communicate either the vacuum path or the irrigation path with the wound <b>200</b>. The three fluid paths for ventilation, vacuum, and irrigation of wound <b>200</b> are provided by multi-lumen tube <b>220</b>.

Multi-lumen tube <b>220</b> includes a vacuum lumen <b>222</b>, an irrigation lumen <b>224</b>, and four outer venting lumens <b>226</b> formed within and defined by a body <b>228</b>, as shown in <figref idref="DRAWINGS">FIG. 21</figref>. Vacuum lumen <b>222</b> is in communication with vacuum source <b>16</b>, irrigation lumen <b>224</b> is in communication with irrigation source <b>18</b>, and each venting lumen <b>226</b> is in communication with the atmosphere through vent <b>219</b>, as is described below. As shown in <figref idref="DRAWINGS">FIGS. 20 and 24</figref>, multi-lumen tube <b>220</b> is coupled to an alternative connector <b>214</b> of member <b>12</b> by Y-connecter <b>212</b>, and is therefore in communication with the wound <b>200</b> at one end <b>230</b> and is coupled to vent <b>260</b> at another end <b>232</b>.

Although tube <b>200</b> is shown to include four venting lumens <b>214</b>, it is within the scope of this disclosure to include a multi-lumen tube having one or more venting lumens in communication with the surrounding atmosphere, one or more vacuum lumens in communication with the vacuum source <b>16</b>, and one or more irrigation lumens in communication with the irrigation source <b>18</b>. Illustratively, an outer diameter <b>234</b> of tube <b>220</b> is 0.375 inch (9.53 mm), a diameter <b>236</b> of vacuum lumen <b>222</b> is 0.125 inch (3.175 mm), a diameter <b>238</b> of irrigation lumen <b>224</b> is 0.125 inch (3.175 mm), and a diameter <b>240</b> of each outer venting lumen <b>226</b> is 0.020 inch (0.508 mm). Although tube <b>220</b> includes the above dimensions, it is within the scope of this disclosure to provide any suitable multi-lumen tube having lumens of any suitable size.

As mentioned above, Y-connecter <b>212</b> is provided for coupling with alternative connector <b>214</b> of vacuum bandage <b>14</b>. Connector <b>214</b> is similar to connector <b>15</b> and is in communication with wound <b>200</b> through channels <b>66</b> and holes <b>67</b> of member <b>12</b>. Connector <b>214</b> is different from connector <b>15</b> in that connector <b>214</b> is positioned at an angle relative to a top surface <b>242</b> of member <b>12</b> and includes a single angled passageway <b>244</b> (as shown in <figref idref="DRAWINGS">FIG. 24</figref>) rather than a vertical passageway connected to a horizontal passageway of connector <b>15</b> (as shown in <figref idref="DRAWINGS">FIG. 3</figref>). In the illustrative embodiment, the included angle between an axis along passageway <b>244</b> and the top surface <b>242</b> of member <b>12</b>, when member <b>12</b> is in a flat configuration, is about 30 degrees.

Illustratively, Y-connecter <b>212</b> includes a bandage portion <b>246</b>, an irrigation portion <b>248</b>, and a vacuum portion <b>252</b>, as shown in <figref idref="DRAWINGS">FIG. 22</figref>. Irrigation portion <b>248</b> includes a passageway <b>254</b> forming a section of the irrigation passageway, vacuum portion <b>252</b> includes a passageway <b>256</b> forming a section of the vacuum passageway, and bandage portion <b>246</b> includes a passageway <b>258</b> forming a section of the vacuum/irrigation passageway. The passageway <b>254</b> of irrigation portion <b>248</b> and the passageway <b>256</b> of vacuum portion <b>252</b> each merge into passageway <b>258</b> of the bandage portion <b>246</b>. Once bandage portion <b>246</b> of Y-connecter <b>212</b> splits into the irrigation portion <b>248</b> and the vacuum portion <b>252</b>, the irrigation and vacuum passageways remain separate and distinct passageways through multi-lumen tube <b>220</b>, vent <b>219</b>, and switch valve <b>250</b> to the respective irrigation source <b>18</b> and vacuum source <b>16</b>.

Bandage portion <b>246</b> is press fit into connector <b>214</b>, as shown in <figref idref="DRAWINGS">FIG. 24</figref>, and includes an angled end <b>260</b> to lie adjacent to the top surface <b>242</b> of member <b>12</b>. Irrigation portion <b>248</b> is similarly press fit into irrigation lumen <b>224</b> of tube <b>220</b> and vacuum portion <b>252</b> is press fit into vacuum lumen <b>222</b> of tube <b>220</b>. In some embodiments, adhesive or sealant is applied to either or all of portions <b>246</b>, <b>248</b>, <b>252</b> to further enhance the connection between bandage portion <b>246</b> and connector <b>214</b> between irrigation portion <b>248</b> and tube <b>220</b>, and between vacuum portion <b>252</b> and tube <b>220</b>. Y-connecter <b>212</b> is provided to connect bandage <b>14</b> with multi-lumen tube <b>220</b> and vent <b>219</b>.

Referring now to <figref idref="DRAWINGS">FIG. 23</figref>, vent <b>219</b> includes a multi-lumen connector <b>262</b> for coupling with multi-lumen tube <b>220</b>, a single-lumen vacuum connector <b>264</b> for coupling with a single-lumen tube, such as tube <b>216</b>, and a single-lumen irrigation connector <b>266</b> for coupling with a single-lumen tube, such as tube <b>218</b> (as shown in <figref idref="DRAWINGS">FIG. 20</figref>). Tubes <b>216</b> and <b>218</b> are also coupled to switch valve <b>250</b> as shown in <figref idref="DRAWINGS">FIG. 20</figref> and described in more detail below. It is also within the scope of this disclosure to eliminate the use of tubes <b>216</b> and <b>218</b> so that vent <b>219</b> is coupled directly to switch valve <b>250</b>. Similar to vents <b>19</b>, <b>119</b>, vent <b>219</b> further includes filter <b>34</b> (shown in phantom), housed within filter housing <b>40</b>, in communication with multi-lumen connector <b>262</b>.

Multi-lumen connector <b>262</b> includes an outer conduit <b>272</b>, an inner vacuum conduit <b>274</b>, and an inner irrigation conduit <b>276</b>, as shown in <figref idref="DRAWINGS">FIG. 23</figref>. Both vacuum conduit <b>274</b> and irrigation conduit <b>276</b> are located within outer conduit <b>272</b>. An edge <b>278</b> of outer conduit <b>272</b> is substantially coplanar with an edge <b>281</b> of vacuum conduit <b>274</b> and an edge <b>282</b> of irrigation conduit <b>276</b>. Vacuum conduit <b>274</b> is in communication with vacuum source <b>16</b> through switch valve <b>250</b> and defines a portion of the vacuum passageway. Irrigation conduit <b>276</b> is in communication with the irrigation source <b>18</b> through switch valve <b>250</b> and defines a portion of the irrigation passageway. Outer conduit <b>252</b> is in communication with the surrounding atmosphere and defines a portion of the vent passageway.

As shown in <figref idref="DRAWINGS">FIG. 24</figref>, vacuum conduit <b>274</b> is received within vacuum lumen <b>222</b> of tube <b>220</b>. Body <b>228</b> of tube <b>220</b>, which includes outer venting lumens <b>226</b>, is received within a space <b>284</b> defined between a cylindrical inner surface <b>286</b> of outer conduit <b>272</b> and cylindrical outer surfaces <b>288</b>, <b>290</b> of vacuum and irrigation conduits <b>274</b>, <b>276</b>, respectively (as shown in <figref idref="DRAWINGS">FIG. 23</figref>). Tube <b>220</b> is press fit into the space <b>284</b> so that the outer surface of tube <b>220</b> abuts cylindrical inner surface <b>286</b> of outer conduit <b>272</b>, so that an inner surface of vacuum lumen <b>220</b> abuts the cylindrical outer surface <b>288</b> of the vacuum conduit <b>274</b>, and so that the inner surface of irrigation lumen <b>224</b> abuts the cylindrical outer surface <b>290</b> of the irrigation conduit <b>276</b>. In some embodiments, an adhesive material or sealant is applied to the appropriate surfaces of tube <b>220</b> and multi-lumen connector <b>262</b> to enhance the connection between tube <b>220</b> and vent <b>219</b>.

As shown in <figref idref="DRAWINGS">FIG. 23</figref>, a ridge or stop (not shown) is coupled to and positioned between outer surface <b>288</b> of vacuum conduit <b>274</b> and outer surface <b>290</b> of irrigation conduit <b>276</b> to prevent tube <b>220</b> from being inserted too far within connector <b>262</b> and thus sealing off outer lumens <b>226</b>. The stop prevents vent passageway from becoming closed off and keeps vent passageway open to receive air from the surrounding atmosphere. Illustratively, vent <b>219</b> includes one stop, however, it is within the scope of this disclosure to include a vent having any number of stops or the like to prevent the vent passageway from becoming closed off from the surrounding atmosphere.

Vacuum connector <b>264</b> of vent <b>219</b> includes an inner surface <b>292</b> defining a portion of the vacuum passageway and an outer surface <b>294</b>. Vacuum connector <b>264</b> is in communication with vacuum conduit <b>274</b> of multi-lumen connector <b>262</b>, as shown in phantom in <figref idref="DRAWINGS">FIGS. 23 and 24</figref>. Illustratively, single-lumen tube <b>216</b>, coupled to vacuum source <b>16</b>, is press fit into vacuum connector <b>264</b>, as shown in <figref idref="DRAWINGS">FIG. 24</figref>. Tube <b>216</b> may further be permanently or temporarily bonded to vacuum connecter <b>264</b> through the use of an adhesive material applied to the appropriate surfaces of tube <b>216</b> and connecter <b>264</b>.

Irrigation connector <b>266</b> of vent <b>219</b> similarly includes an inner surface <b>296</b> defining a portion of the irrigation passageway and an outer surface <b>298</b> including a shoulder <b>300</b>. Irrigation connector <b>266</b> is in communication with irrigation conduit <b>276</b> of multi-lumen connector <b>262</b>, also shown in <figref idref="DRAWINGS">FIGS. 23 and 24</figref>. Illustratively, single-lumen tube <b>218</b> is press-fit into irrigation connector <b>266</b>, as shown in <figref idref="DRAWINGS">FIG. 24</figref>. Tube <b>218</b> may further be permanently or temporarily bonded to irrigation connector <b>266</b> through the use of an adhesive material applied to the appropriate surfaces of tube <b>218</b> and connector <b>266</b>. It is within the scope of this disclosure, however, to connect tubes <b>216</b> and <b>218</b> to the respective irrigation and vacuum connectors <b>266</b>, <b>264</b> through the use of a barb or a luer lock connection, for example.

Outer conduit <b>272</b> of multi-lumen connector <b>262</b> further includes an opening or aperture <b>302</b> in communication with the surrounding atmosphere. Housing <b>40</b> for filter <b>34</b> is coupled to multi-lumen connector <b>262</b> so that a passageway <b>46</b> of housing <b>40</b> connects space <b>284</b> with the filter <b>34</b> and the surrounding atmosphere. Passageway <b>46</b> extends radially away from outer conduit <b>272</b> and is generally perpendicular to an axis running through vacuum conduit <b>274</b>. Passageway <b>46</b> is defined by cylindrical wall <b>27</b>.

In operation, vent <b>219</b> is used during both vacuum and irrigation modes of the system. As mentioned before with respect to vents <b>19</b> and <b>119</b>, vent <b>219</b> provides increased air flow through bandage <b>14</b> and above wound <b>200</b>. Vent <b>219</b> also creates an open system and prevents the system from becoming static. Vent <b>219</b> further maintains separate vacuum and irrigation passageways. As mentioned before with respect to vents <b>19</b>, <b>119</b>, it is within the scope of the disclosure for the caregiver to close off vent <b>160</b> while vacuuming or irrigating wound <b>200</b>. Vent <b>219</b> may also be closed in a number of ways. For example, a cap or a valve (not shown) may be coupled to filter <b>34</b> or filter housing <b>40</b> to prevent air flow through filter <b>34</b>. It is within the scope of this disclosure to include a vent having other suitable means of preventing air flow therethrough.

Referring now to <figref idref="DRAWINGS">FIGS. 25-28</figref>, the stopcock <b>250</b> of system <b>210</b> includes a diverter or handle <b>314</b> and a body <b>316</b> defining an aperture <b>318</b> for receiving at least a portion of the handle <b>314</b>. Handle <b>314</b> includes a grip <b>320</b> and a hub or stem <b>322</b> coupled to the grip <b>320</b>. Hub <b>322</b> is received within aperture <b>318</b> of body <b>316</b>. Stopcock or switch valve <b>250</b> further includes a vacuum conduit <b>310</b> having a first portion <b>324</b> coupled to tube <b>216</b> and a second portion <b>326</b> coupled to a single-lumen tube <b>328</b>, as shown in <figref idref="DRAWINGS">FIG. 20</figref>. Tube <b>328</b>, is coupled to vacuum source <b>16</b>, as shown in <figref idref="DRAWINGS">FIG. 20</figref>. As shown in <figref idref="DRAWINGS">FIGS. 25-28</figref>, vacuum conduit <b>310</b> defines a portion of the vacuum passageway through body <b>316</b>. Each single-lumen tube <b>216</b>, <b>328</b> is coupled to the respective first portion <b>324</b> and second portion <b>326</b> of the stopcock <b>250</b> through the use of luer locks (not shown). It is within the scope of this disclosure, however, to connect tubes <b>216</b>, <b>328</b> to stopcock <b>250</b> in another suitable manner such as through the use of a barb, by press-fitting each tube <b>216</b>, <b>328</b> onto conduit <b>310</b> of stopcock <b>250</b>, or by slip-fitting each tube <b>216</b>, <b>328</b> into conduit <b>310</b>, and including the use of adhesive material to permanently or temporarily bond each tube <b>216</b>, <b>328</b> to conduit <b>310</b>.

Stopcock <b>250</b> further includes an irrigation conduit <b>330</b> having a first portion <b>332</b> coupled to tube <b>218</b> and a second portion <b>334</b> coupled to a single-lumen tube <b>336</b>. Tube <b>336</b> is coupled to irrigation source <b>18</b>, as shown in <figref idref="DRAWINGS">FIG. 20</figref>. Irrigation conduit <b>330</b> defines a portion of the irrigation passageway through body <b>316</b> of stopcock <b>250</b>. As shown in <figref idref="DRAWINGS">FIG. 25</figref>, irrigation conduit <b>330</b> lies below vacuum conduit <b>310</b> as indicated by a distance <b>311</b> so that the irrigation conduit <b>330</b> and vacuum conduit <b>310</b> are positioned to lie in separate horizontal planes. Tubes <b>218</b>, <b>336</b> may be coupled to irrigation conduit <b>330</b> by the same or similar means as those discussed above with respect to tubes <b>216</b>, <b>328</b> and vacuum conduit <b>310</b>.

Hub <b>322</b> of handle <b>314</b> includes a first or vacuum cut-out portion <b>340</b> and a second or irrigation cut-out portion <b>342</b>. Similar to conduits <b>310</b> and <b>330</b>, cut-out portions <b>340</b>, <b>342</b> do not lie in the same horizontal plane. When hub <b>322</b> is received within aperture <b>318</b> of body <b>316</b>, vacuum cut-out portion <b>340</b> lies in the same horizontal plane as vacuum conduit <b>310</b> and irrigation cut-out portion <b>342</b> lies in the same horizontal plane as irrigation conduit <b>330</b>.

Handle <b>314</b>, and thus hub <b>322</b>, is rotatable relative to body <b>316</b>. Handle <b>314</b> is able to be positioned by a caregiver to align the vacuum cut-out portion <b>340</b> with the vacuum conduit <b>310</b>, as shown in <figref idref="DRAWINGS">FIG. 26</figref>, or to align the irrigation cut-out portion <b>342</b> with the irrigation conduit <b>330</b>, as shown in <figref idref="DRAWINGS">FIG. 27</figref>. Further, handle <b>314</b> may be rotated to an “off” position where neither cut-out portion <b>340</b>, <b>342</b> is aligned with either of the conduits <b>310</b>, <b>330</b>, as shown in <figref idref="DRAWINGS">FIG. 28</figref>. Thus, passageways <b>344</b>, <b>346</b> through conduits <b>310</b>, <b>330</b> each communicate with aperture <b>318</b> of body <b>316</b>.

Referring to <figref idref="DRAWINGS">FIG. 26</figref>, the stopcock <b>250</b> is in a vacuum position where vacuum cut-out portion <b>340</b> is aligned with vacuum conduit <b>310</b>, as mentioned above. Vacuum cut-out portion <b>340</b> connects first portion <b>324</b> of vacuum conduit <b>310</b> with second <b>326</b> of vacuum conduit <b>310</b> so that vacuum source <b>16</b> is able to create a negative pressure adjacent the wound <b>200</b>. When stopcock <b>250</b> is in the vacuum position, irrigation cut-out portion <b>342</b> is not in communication with the irrigation conduit <b>330</b>.

Rotating handle <b>314</b> about 90 degrees clockwise from the vacuum position aligns irrigation cut-out portion <b>342</b> with irrigation conduit <b>330</b> in an irrigation position shown in phantom in <figref idref="DRAWINGS">FIG. 27</figref>. Irrigation cut-out portion <b>342</b> connects first end <b>332</b> of irrigation conduit <b>330</b> with second end <b>334</b> of irrigation conduit <b>330</b> so that the irrigation source <b>18</b> is able to send fluids through stopcock <b>250</b> to wound <b>200</b>. When stopcock <b>250</b> is in the irrigation position, vacuum cut-out portion <b>340</b> is not in communication with the vacuum conduit <b>310</b>.

To move the stopcock <b>250</b> to the “off” position (shown in <figref idref="DRAWINGS">FIG. 28</figref>), the caregiver may either rotate the handle 180 degrees in either direction from the irrigation position (shown in <figref idref="DRAWINGS">FIG. 27</figref>) or the caregiver may rotate the handle 90 degrees in the counter-clockwise direction from the vacuum position (shown in <figref idref="DRAWINGS">FIG. 26</figref>). As mentioned above, neither cut-out portion <b>340</b>, <b>342</b> communicates with either conduit <b>310</b>, <b>330</b> when stopcock <b>250</b> is in the “off” position.

As shown in <figref idref="DRAWINGS">FIG. 25</figref>, grip <b>320</b> of handle <b>314</b> includes an indicator <b>350</b> to indicate to the caregiver whether the stopcock <b>250</b> is in the vacuum position, irrigation position, or off position. It is within the scope of this disclosure to include a seal, gasket, or o-ring (not shown) between hub <b>322</b> and body <b>316</b> of stopcock <b>250</b> to create a seal between the two components.

Looking now to <figref idref="DRAWINGS">FIGS. 29 and 30</figref>, yet another wound care bandage system <b>400</b> is provided which has the capability to create negative pressure adjacent wound <b>200</b>, to irrigate wound <b>200</b>, and to ventilate wound <b>200</b>. Ventilated vacuum bandage system <b>400</b> is provided for use with wound <b>200</b> having a wound surface <b>413</b>. The system <b>400</b> includes a wound dressing member <b>419</b> similar to wound dressing member <b>12</b>, shown in <figref idref="DRAWINGS">FIG. 24</figref>, a vacuum source <b>16</b>, an irrigation source <b>18</b>, and a vent <b>460</b> in communication with the member <b>419</b>. The vent <b>460</b> is also in communication with the surrounding atmosphere to provide increased air flow above the wound surface <b>413</b> and through the member <b>419</b> particularly when the vacuum source <b>16</b> is operating to create a negative pressure above the wound <b>200</b>. As is herein defined with respect to all embodiments disclosed herein, the term “vent” is or includes any passageway to the atmosphere, unless noted otherwise.

In one illustrative embodiment, a vacuum bandage <b>410</b> is provided for use with wound <b>200</b> having wound surface <b>413</b>, shown in <figref idref="DRAWINGS">FIG. 30</figref>. Bandage <b>410</b> includes the wound dressing member <b>419</b> and a vent <b>460</b> in communication with member <b>419</b> as shown in <figref idref="DRAWINGS">FIGS. 29 and 30</figref>. Member <b>419</b> is illustratively thin and flexible and includes a wound contacting layer <b>420</b> and a cover <b>422</b> coupled to the layer <b>420</b>. Member <b>419</b> also includes a connector <b>423</b> coupled to cover <b>422</b> for communication with vacuum source <b>16</b> and/or irrigation source <b>18</b>.

Vacuum bandage <b>410</b> is coupled to vacuum source <b>16</b> and irrigation source <b>18</b> through the use of a switch valve <b>455</b>, as shown diagrammatically in <figref idref="DRAWINGS">FIG. 29</figref>. Switch valve <b>455</b> may be the same as or similar to stopcock <b>50</b> and/or assemblies <b>80</b>, <b>180</b>, described above, for example. Similar to bandage <b>14</b>, bandage <b>410</b> also promotes the healing of large wound <b>200</b> by providing vacuum therapy to the wound <b>200</b> to promote blood flow and remove exudate from wound surface <b>413</b> and by providing for irrigation of the wound <b>200</b> with fluids such as saline, for example.

Vent <b>460</b> of system <b>400</b> is provided for increased air flow through bandage <b>410</b> and above wound <b>200</b> while vacuum source <b>16</b> applies suction to wound <b>200</b>. Without vent <b>460</b>, a generally closed system is created between vacuum bandage <b>10</b> and vacuum source <b>14</b>. Vent <b>460</b>, similar to vents <b>19</b>, <b>119</b>, <b>219</b> discussed above, acts to prevent the system <b>400</b> from becoming static by drawing air in from the surrounding atmosphere around bandage <b>410</b>. Air is drawn through vent <b>460</b> to bandage <b>410</b> to create airflow above wound <b>200</b>, through member <b>419</b>, and out through a vacuum tube <b>441</b> coupled to vacuum source <b>16</b>. A wound care technique disclosing ventilation of the wound is provided in the article “No wound is too big for resourceful nurses” by Margaret Wooding-Scott, RN, CCRN, Barbara Ann Montgomery, RN, ET, and Deborah Coleman, RN, MS, CS as published in the December 1988 edition of the magazine RN.

Referring now to member <b>419</b>, layer <b>420</b>, cover <b>422</b>, and connecter <b>423</b> are each made of a medical grade silicone or other type of pliable elastomer. Two companies, for example, which manufacture such medical grade silicone are GE Silicones and NuSil Technology. It is within the scope of this disclosure, however, to include a member made of any suitable type of material. Illustratively, member <b>419</b> is made of material that is non-porous and non-foam-like. This thin, flexible material is also generally non-absorptive. For example, materials such as polyvinylchloride (PVC), PVC free of diethylhexyl phthalate (DEHP-free PVC), polyurethane, or polyethylene may be used in the manufacture of member <b>419</b>. However, as mentioned above, it is within the scope of this disclosure to include a bandage having a member made of any suitable material to communicate the negative pressure from the vacuum source to the wound. Further, layer <b>420</b>, cover <b>422</b>, and connecter <b>423</b> may each be molded to include anti-microbial constituents. For example, it is within the scope of this disclosure to impregnate member <b>419</b> with silver ions which are known anti-microbials.

Illustratively, member <b>419</b>, including layer <b>420</b>, cover <b>422</b>, and connecter <b>423</b>, is also made of a generally non-adhesive material. Therefore, wound contacting layer <b>420</b>, which lies generally adjacent to the wound surface <b>413</b>, does not adhere to the wound surface <b>413</b>. Further, member <b>419</b> is illustratively solid in nature and generally non-compressible. Member <b>419</b> is also illustratively transparent. Therefore, a caregiver or user is able to see the wound <b>200</b> through member <b>419</b> when member <b>419</b> is placed adjacent to wound surface <b>413</b>. This transparency allows the caregiver to view the progress of the healing of the wound <b>200</b>.

Layer <b>420</b> includes a wound facing surface <b>424</b> and an upper or opposite surface <b>426</b>. Wound facing surface <b>424</b>, or portions thereof, contact and conform to the wound surface <b>413</b>. Opposite surface <b>426</b> includes a central area <b>428</b> and a plurality of channels <b>430</b> spaced-apart from and extending radially away from central area <b>428</b>. Central area <b>428</b> is recessed relative to the portions of upper surface <b>426</b> between channels <b>430</b>. As shown in <figref idref="DRAWINGS">FIG. 29</figref>, channels <b>430</b> are open at the sides and ends of member <b>419</b>. Opposite surface <b>426</b> further includes concentric channels <b>431</b>. Illustratively, each channel <b>430</b>, <b>431</b> is 0.030 inch (0.762 mm) wide and 0.030 inch (0.762 mm) deep. It is within the scope of this disclosure, however, to include channels <b>430</b>, <b>431</b> of opposite surface <b>426</b> having other suitable widths and depths suitable for the present application. Central area <b>428</b> of layer <b>420</b> is provided to communicate with the vacuum source <b>16</b> and irrigation source <b>18</b> through a port <b>440</b> of cover <b>422</b>, as will be described below.

Illustratively, a plurality of radially extending protrusions or bosses <b>432</b> are positioned around central area <b>428</b>. Bosses <b>432</b> are positioned between central area <b>428</b> and channels <b>430</b>, <b>431</b>, as shown in <figref idref="DRAWINGS">FIG. 29</figref>. Bosses <b>432</b> are provided to prevent central area <b>428</b> from collapsing in on port <b>440</b> of cover <b>422</b> to form a seal and effectively block air flow through port <b>440</b> while suction is applied to the bandage <b>410</b>. Port <b>440</b> communicates with the vacuum source <b>16</b> and/or the irrigation source <b>18</b> via connecter <b>423</b> and tube <b>441</b>, as shown in <figref idref="DRAWINGS">FIGS. 29 and 30</figref>. Tube <b>441</b> is coupled to connecter <b>423</b> by a barbed tube coupler <b>498</b>, similar to tube coupler <b>11</b> described above. Tube <b>441</b> may also be coupled directly to connecter <b>423</b>.

As mentioned above, port <b>440</b> is in communication with central area <b>428</b> of layer <b>420</b>. Illustratively, four bosses <b>432</b> are shown in <figref idref="DRAWINGS">FIG. 29</figref>. However, it is within the scope of this disclosure to provide any number of bosses <b>423</b> or the like around central area <b>428</b> of layer <b>420</b> to prevent central area <b>428</b> from sealing off port <b>440</b> of cover <b>422</b> as suction is applied to bandage <b>410</b>. Further, it is within the scope of this disclosure to include a boss or bosses having any shape in order to prevent central area <b>428</b> from sealing off port <b>440</b> when vacuum source <b>16</b> is running.

Connecter <b>423</b>, as shown in <figref idref="DRAWINGS">FIGS. 29 and 30</figref> is a tubal port coupled to a top surface <b>436</b> of cover <b>422</b> and in communication with port <b>440</b> of cover <b>422</b>. As mentioned before, it is within the scope of this disclosure for connector <b>423</b> to be a separate component of member <b>419</b> which is coupled to cover <b>422</b> or for connecter <b>423</b> to be coupled to cover <b>422</b> by being molded integrally with cover <b>422</b>. Connector <b>423</b> includes a passageway formed at a right-angle. Thus, the passageway in connecter <b>423</b> has a vertical portion <b>425</b> that communicates with port <b>440</b> and a horizontal portion <b>427</b> that communicates with vertical portion <b>425</b>. Connector <b>423</b> connects with tube <b>441</b> through the coupler <b>498</b> to provide a horizontal tube attachment for tube <b>441</b>. Cover <b>422</b> includes a bottom surface <b>434</b> and top surface <b>436</b>, as shown in <figref idref="DRAWINGS">FIG. 29</figref>. Bottom surface <b>434</b> engages opposite surface <b>426</b> of layer <b>420</b>, as shown in <figref idref="DRAWINGS">FIG. 30</figref>.

In some embodiments, member <b>419</b> is formed by heat sealing opposite surface <b>426</b> of layer <b>420</b> and bottom surface <b>434</b> of cover <b>422</b> together and by heat sealing connecter <b>423</b> to top surface <b>436</b> of cover <b>422</b>. For example, each of connecter <b>423</b>, cover <b>422</b> (or the combination of cover <b>422</b> and connecter <b>423</b>), and layer <b>420</b> may be pre-shaped and formed from semi-cured silicone. Once the connecter <b>423</b>, cover <b>422</b>, and layer <b>420</b> are placed together appropriately, the entire member <b>419</b> may be heated to heat seal and cure each of the three components to one another. Alternatively, for example, the cover <b>422</b> only may be made from semi-cured silicone while the connecter <b>423</b> and layer <b>420</b> may be made from fully cured silicone. Once placed together and heated, connecter <b>423</b> and layer <b>420</b> will heat seal to cover <b>422</b>. Semi-cured silicone may be bought and pre-molded from a manufacturer such as NuSil Technology, for example.

Although the method of heat sealing the cover <b>422</b>, connecter, and layer <b>420</b> to each other is disclosed, it is within the scope of this disclosure to form member <b>419</b> by coupling layer <b>420</b>, cover <b>422</b>, and connector <b>423</b> together by any other suitable means such as through the use of adhesives, for example. Further, it is within the scope of this disclosure to provide a member <b>419</b> where cover <b>422</b> lies adjacent to, but is not coupled to, layer <b>420</b>.

As mentioned above, cover <b>422</b> is coupled to layer <b>420</b> and connecter <b>423</b> is coupled to cover <b>422</b> to form member <b>419</b>. Cover <b>422</b> and layer <b>420</b> cooperate to form distinct passageways <b>442</b> of member <b>419</b> defined by channels <b>430</b>, <b>431</b> of layer <b>420</b> and lower surface <b>434</b> of cover <b>422</b>. Passageways <b>442</b> extend from the outer edges of member <b>419</b> and are in communication with central area <b>428</b> of layer <b>420</b>. Central area <b>428</b> of layer <b>420</b> is in communication with port <b>440</b> of cover <b>422</b> which is in communication with the vacuum and/or irrigation sources <b>16</b>, <b>18</b>, via connecter <b>423</b>, and tube <b>441</b>. Therefore, passageways <b>442</b> are in communication with the vacuum and/or irrigation sources <b>16</b>, <b>18</b>.

Layer <b>420</b> includes through holes <b>446</b> which extend from channels <b>430</b>, <b>431</b> to wound facing surface <b>424</b>, as shown in <figref idref="DRAWINGS">FIG. 30</figref>. Illustratively, holes <b>446</b> are distinct and are provided to communicate with channels <b>430</b>, <b>431</b> of layer <b>420</b>. Holes <b>446</b> therefore communicate with passageways <b>442</b> of member <b>419</b> and the vacuum and/or irrigation sources <b>16</b>, <b>18</b> as well to allow the suction from the vacuum source <b>16</b> and/or the fluid from the irrigation source <b>18</b> to reach the wound bed surface <b>413</b> via the holes <b>446</b>. Illustratively, holes <b>46</b> are 0.020 inch (0.508 mm) in diameter and are spaced approximately 0.500 inch (12.700 mm) apart along channels <b>430</b>, <b>431</b> of layer <b>420</b>. It is, however, within the scope of the disclosure to include holes having other suitable sized diameters and/or other suitable spacing that allow for the removal of exudate without clogging.

Bandage <b>410</b> further includes a sealing layer or film <b>450</b> that is placed over cover <b>422</b> and around tube <b>441</b>, as shown in <figref idref="DRAWINGS">FIG. 30</figref>. Film <b>450</b> acts as an outer cover of the bandage <b>410</b> and covers the entire wound <b>412</b> by extending over wound <b>412</b> and attaching to the patient's healthy skin <b>452</b>, also as shown in <figref idref="DRAWINGS">FIG. 30</figref>. Preferably, film <b>450</b> is an occlusive or semi-occlusive material which allows water vapor to permeate through. Because of this characteristic, the film <b>450</b> is referred to as Moisture Vapor Transmission Rate film or MVTR film. The products TEGADERM® brand sealing film made by 3M Corporation, and OPSITE FLEXIGRID® semi-permeable dressing made by Smith &amp; Nephew can be used for film <b>450</b>, for example. Film <b>450</b> is approximately 0.003 inch (0.076 mm) thick. However, it is within the scope of this disclosure to include any occlusive or semi-occlusive film <b>450</b> having another thickness. Film <b>450</b> is provided to create a sealed environment below the film <b>450</b> and around the wound <b>200</b> in which a vacuum or negative pressure can be maintained as provided by vacuum source <b>16</b>. Film <b>450</b> therefore creates a vacuum space <b>453</b> below film <b>450</b> and above wound surface <b>413</b>.

As shown in <figref idref="DRAWINGS">FIG. 30</figref>, sealing film <b>450</b> is positioned adjacent to top surface <b>436</b> of cover <b>422</b>. It is within the scope of this disclosure, however, for bandage <b>410</b> to further include a packing material or filler such as gauze, for example, positioned between film <b>450</b> and member <b>419</b>.

It is also within the scope of this disclosure to provide a bandage (not shown) having a self-sealing member which seals about the wound <b>412</b> to the patient's healthy skin <b>27</b> to provide a vacuum space between the member and the wound surface <b>413</b>. In other words, it is within the scope of this disclosure to include a bandage having a sealing means without the use of sealing film <b>450</b>. For example, it is within the scope of this disclosure to include a wound contacting layer of the member having an adhesive positioned about the outer perimeter of the wound contacting surface of the layer. The adhesive perimeter would be provided to seal to the patient's healthy skin <b>27</b> surrounding wound <b>200</b>. The adhesive would, therefore, permit the member to be self-sealing such that a vacuum or negative pressure can be created and maintained above wound surface <b>413</b> without the use of sealing film <b>450</b>. It is also within the scope of this disclosure to provide any member having an adhesive for attachment to the patient's healthy skin surrounding the wound so that the member is self-sealing and able to maintain a negative pressure above the wound without the use of a sealing film. For example, the wound contacting layer may be sized smaller than the cover and the bottom surface of the cover may include an outer adhesive perimeter for coupling with the patient's surrounding healthy skin.

As shown in <figref idref="DRAWINGS">FIG. 30</figref>, member <b>419</b> of bandage <b>410</b> has a smooth wound facing surface <b>424</b>. Wound facing surface <b>424</b> may also be textured or roughened and/or may include ribs, protrusions, channels, or spacers, or a single rib, protrusion, channel or spacer design. By providing member <b>419</b> with one or more ribs, protrusions, channels, spacers, etc., a space is created between surface <b>424</b> of layer <b>420</b> and wound surface <b>413</b>. Through holes <b>446</b> communicate with this space to permit vacuum source <b>16</b> to establish a generally uniformly distributed vacuum or negative pressure to the wound surface <b>413</b> to draw blood from the body to the wound surface <b>413</b> and to draw exudate from the wound <b>412</b> through holes <b>446</b>, into channels <b>430</b>, <b>431</b> and passageways <b>442</b>, and out port <b>440</b> of cover <b>422</b>.

Although bandage <b>410</b> is described above, it is within the scope of this disclosure for the ventilated vacuum bandage system to include any suitable bandage or wound dressing member coupled to the vacuum source <b>16</b> to communicate negative pressure from the vacuum source <b>16</b> to the wound <b>412</b>. Bandage <b>410</b>, therefore, is merely an illustrative bandage for use with the wound care bandage systems disclosed herein.

The vacuum or negative pressure which draws blood from the body to the wound surface <b>413</b> and draws exudate from the wound <b>200</b> up through member <b>419</b> promotes the healing of wound <b>200</b>. As wound <b>200</b> heals, granulations form along the wound surface <b>413</b>. Granulations, therefore, are the replacement within the wound bed of tissue lost. As the granulations fill in the wound bed causing the wound <b>200</b> to heal, member <b>419</b> rides up on the wound surface <b>413</b> on top of the granulations which are formed.

As mentioned above, port <b>440</b> of cover <b>422</b> communicates with vacuum source <b>16</b> and/or irrigation source <b>18</b> via connecter <b>423</b> and tube <b>441</b>. As shown in <figref idref="DRAWINGS">FIG. 29</figref>, switch valve <b>455</b> is provided which allows the caretaker to switch between the use of the vacuum source <b>16</b> and the irrigation source <b>18</b>. It will be appreciated that a mechanism other than the switch valve <b>455</b> may be used to selectively couple the vacuum source <b>16</b> or the irrigation source <b>18</b> to the bandage <b>410</b>. Simple tube clamps, for example, may be used selectively to open and close the tube set provided with bandage <b>410</b>. When valve <b>455</b> is switched to operate the vacuum source <b>16</b>, the vacuum suction draws exudate up through holes <b>446</b> and radially inwardly through passageways <b>442</b> toward port <b>440</b> and finally through connecter <b>423</b> and tube <b>441</b>. Although tube <b>441</b> has been referred to as vacuum tube <b>441</b>, tube <b>441</b> may also be used as an irrigation tube carrying liquid to the wound <b>200</b> from irrigation source <b>18</b>, as described above.

As mentioned above, bandage <b>410</b> includes vent <b>460</b> similar to vents <b>19</b>, <b>119</b>, <b>219</b> described above. Vent <b>460</b> also operates to increase air flow through the wound <b>200</b> and the passageways <b>442</b> of member <b>419</b> while vacuum source <b>16</b> applies suction to wound <b>200</b>. Without vent <b>460</b> a generally closed system is created between vacuum bandage <b>410</b> and vacuum source <b>414</b>. For example, in bandages without vent <b>460</b>, once the requisite amount of air in the tubing <b>441</b> and below sealing film <b>450</b> within vacuum space <b>453</b> has been removed by the vacuum source <b>16</b> to create a predetermined negative pressure at wound surface <b>413</b>, it is possible for the system to become generally static inhibiting much, if any, fluid flow from wound surface <b>413</b> through passageways <b>442</b> and out port <b>440</b> and connector <b>423</b>. Vent <b>460</b>, however, opens the system to aspirate the passageways <b>442</b> and tube <b>41</b> of the system which promotes removal of debris that may be clogging the system.

Vent <b>60</b> acts as a first port of bandage <b>410</b> and port <b>440</b> of member <b>419</b> acts as a second port of bandage <b>410</b>. Bandage <b>410</b>, therefore, includes a first port in communication with the surrounding atmosphere above or around bandage <b>410</b> and a second port in communication with the vacuum source <b>16</b>. When vacuum source <b>16</b> is running, a pressure differential is initially created as vacuum source <b>16</b> draws more air out from beneath sealing film <b>450</b> than is drawn in from the surrounding atmosphere through vent <b>460</b>. Therefore, a negative pressure is created above wound <b>200</b>. Once a desired negative pressure above wound <b>200</b> is reached, that negative pressure may be maintained so that the amount of air flow into the bandage through vent <b>460</b> is generally equal to the amount of air flow out of the bandage <b>410</b> through connecter <b>423</b> and tube <b>441</b> by vacuum source <b>16</b>. The two ports of bandage <b>410</b> allow an air flow current to be created beneath the film <b>450</b> to generally prevent the bandage <b>410</b> and vacuum source <b>16</b> system from becoming static.

As shown in <figref idref="DRAWINGS">FIGS. 29 and 30</figref>, vent <b>460</b> comprises a vent line or tube <b>462</b> having a first end <b>464</b> and an opposite second end <b>466</b>. Illustrative vent line <b>462</b> runs parallel to tube <b>441</b> and is coupled to tube <b>441</b> by one or more couplers <b>468</b>, as shown in <figref idref="DRAWINGS">FIGS. 30 and 31</figref>. First end <b>464</b> is positioned to lie below sealing film <b>450</b> and above member <b>419</b>. As shown in <figref idref="DRAWINGS">FIG. 30</figref>, first end <b>464</b> is adjacent top surface <b>436</b> of cover <b>422</b> and second end <b>466</b> of vent line <b>462</b> is positioned outside the vacuum space <b>453</b> defined between wound surface <b>413</b> and sealing film <b>450</b>. Thus, second end <b>466</b> communicates with the surrounding atmosphere to draw air from the surrounding atmosphere into the system and through passageways <b>442</b> of member <b>419</b>. Although vent <b>460</b> is illustrated as a tube, it is within the scope of this disclosure for vent <b>460</b> to include any type of conduit or passage which provides communication between the atmosphere surrounding the bandage <b>410</b> and the passageways <b>442</b> of the bandage <b>410</b>.

An air filter <b>470</b> similar to filter <b>34</b>, described above, is coupled to second end <b>466</b> of vent line <b>462</b> as shown in <figref idref="DRAWINGS">FIGS. 29 and 30</figref>. Illustratively, air filter <b>470</b> is a 0.2 micron anti-microbial filter for preventing bacteria and other microorganisms in the atmosphere from entering the wound space below film <b>450</b>. Filter <b>470</b> is also hydrophobic. Such an air filter, for example, is made by W.L. Gore &amp; Associates, Inc. of Elkton, Md. A cap or a valve <b>472</b> is also coupled to second end <b>466</b> of vent line <b>462</b>. As shown in <figref idref="DRAWINGS">FIGS. 29 and 30</figref>, filter <b>470</b> is positioned between end <b>466</b> and valve <b>472</b>. Valve <b>472</b> allows a user to manually control and adjust the amount of air flow into vent line <b>462</b>. For example, valve <b>472</b> is movable between a fully closed position and a fully opened position. In the fully closed position, no air flow is permitted through valve <b>472</b> and the system operates as a closed system. In the fully open position, a maximum amount of air is drawn in through the valve <b>472</b> and vent line <b>462</b> so that the system operates as an open system to aspirate the passageways <b>442</b> of member <b>419</b> and create fluid flow throughout the system. The valve <b>472</b> is also adjustable to any desired partially open position between the fully closed position and the fully open position. Therefore, the amount of air flow through vent line <b>462</b> is adjustable by the caregiver.

While the valve <b>472</b> is open or partially open and air is being drawn in through vent line <b>462</b>, vacuum source <b>16</b> will maintain a negative pressure under sealing film <b>450</b> while vacuum source <b>16</b> is operating. In other words, the vacuum bandage <b>410</b> and vacuum source <b>16</b> act to initially vent less air into the system than is vacuumed out of the system to create a negative pressure above the wound <b>200</b>. Once created, the negative pressure above the wound <b>200</b> is maintained by vacuum source <b>16</b> when vent line <b>462</b> is open. For example, even though vent line <b>462</b> is open, vacuum source <b>16</b> is still able to create a negative pressure above wound <b>200</b> as a result of the pneumatic resistance provided by the vent <b>460</b>. The vent line <b>462</b> and air filter <b>470</b> create pneumatic resistance to the entry of air from the surrounding atmosphere into the space <b>453</b> above the wound <b>200</b> when the valve <b>472</b> is open, thus enabling the net effect to be a negative pressure above the wound <b>200</b> created by the vacuum source <b>16</b>. In preferred embodiments, vent <b>460</b> is open or partially open while the vacuum source <b>16</b> is operating. It is within the scope of the disclosure, however, to close the vent <b>460</b> while the vacuum source is running.

Although vent line <b>462</b> is shown to run parallel to tube <b>441</b>, it is within the scope of this disclosure to position vent line <b>462</b> anywhere so long as first end <b>464</b> is positioned below sealing film <b>450</b> and second end <b>466</b> communicates with the surrounding atmosphere. Vent line <b>462</b> of the embodiment of <figref idref="DRAWINGS">FIGS. 29-31</figref> comprises a separate tube formed independently from tube <b>441</b> and coupled to tube <b>441</b> by couplers <b>468</b>, such as medical tape wrapped around tube <b>441</b> and vent line <b>462</b>. <figref idref="DRAWINGS">FIGS. 32-33</figref>, as well as <figref idref="DRAWINGS">FIG. 4</figref>, described above, illustrate the cross sections of various alternative vent lines and vacuum/irrigation tube combinations.

The embodiments shown in <figref idref="DRAWINGS">FIGS. 32 and 33</figref> as well as <figref idref="DRAWINGS">FIG. 4</figref> illustrate parallel vent lines and vacuum/irrigation tubes which do not require a coupler <b>68</b>, for example, to maintain their parallel relationship. A vent line and vacuum tube combination <b>480</b> is shown in <figref idref="DRAWINGS">FIG. 32</figref>. Combination <b>480</b> includes vent line passageway <b>482</b> and vacuum/irrigation passageway <b>484</b> separated from vent line passageway <b>482</b> by a partition <b>486</b>. As shown in <figref idref="DRAWINGS">FIG. 32</figref>, combination <b>480</b> has a circular cross-section defined by an outer wall <b>488</b>. Combination <b>480</b> is extruded or manufactured as a single tube having two passages or lumens, whereas vent line <b>462</b> and tube <b>441</b> of <figref idref="DRAWINGS">FIG. 31</figref> are extruded or manufactured separately.

Another illustrative vent line and vacuum/irrigation tube combination <b>490</b> is shown in <figref idref="DRAWINGS">FIG. 33</figref>. In combination <b>490</b>, vent line <b>462</b> and tube <b>441</b> are integrally coupled to each other. As illustrated, vent line <b>462</b> includes an outer wall <b>492</b> and tube <b>441</b> includes an outer wall <b>494</b>. A portion of outer wall <b>492</b> is integrally coupled to a portion of outer wall <b>494</b>. An external coupler <b>468</b>, for example, is not required to maintain the parallel relationship of vent line <b>462</b> and tube <b>441</b> of combination <b>490</b>. Further, combination <b>490</b> is extruded or manufactured as a single tube having two passages or lumens.

Yet another illustrative vent line and vacuum/irrigation tube combination is shown in <figref idref="DRAWINGS">FIG. 4</figref> as multi-lumen tube <b>20</b> and was discussed above with reference to system <b>10</b>. Multi-lumen tube is a single multi-lumen tube having outer wall <b>25</b> and a central, inner lumen or vacuum passageway <b>22</b>. Passageway <b>22</b> may be coupled at one end to either the vacuum source <b>16</b> or the irrigation source <b>18</b> of system <b>410</b> and may be coupled at the other end to connecter <b>423</b> of member <b>419</b> via the barbed coupler <b>498</b>, as shown in <figref idref="DRAWINGS">FIG. 3</figref>, and described in more detail below. As mentioned above with respect to system <b>10</b>, multi-lumen tube <b>20</b> further includes four outer lumens or air vent passageways <b>24</b>. Passageways <b>24</b> are formed within outer wall <b>25</b> and around central passageway <b>22</b>. Passageways <b>24</b> are in communication with the atmosphere surrounding bandage <b>410</b> at one end and are in communication with the vacuum space <b>453</b> below sealing film <b>450</b>. Combination <b>500</b> is also extruded or manufactured as a single tube.

As shown in <figref idref="DRAWINGS">FIGS. 29 and 30</figref>, barbed tube coupler <b>498</b> is received within tube <b>441</b> and horizontal passageway <b>427</b> of connector <b>423</b>. Coupler <b>498</b> includes ridges <b>499</b> for preventing coupler <b>498</b> from separating from either tube <b>441</b> or connector <b>423</b>. The vent line and vacuum tube combinations <b>480</b>, <b>490</b> of <figref idref="DRAWINGS">FIGS. 32 and 33</figref> as well as multi-lumen tube <b>20</b> of <figref idref="DRAWINGS">FIG. 4</figref>, are also coupled to connector <b>423</b> via coupler <b>498</b>. For example, coupler <b>498</b> is received within tube passageway <b>484</b> of vent line and vacuum tube combination <b>480</b> leaving vent line passageway <b>482</b> free to draw air into the bandage <b>410</b> from the surrounding atmosphere. Coupler <b>498</b> is also received within tube <b>441</b> of combination <b>490</b> and vacuum passageway <b>22</b> of multi-lumen tube <b>20</b>. It is within the scope of this disclosure to further include combinations <b>480</b>, <b>490</b> where vent line passageway <b>482</b> and vent line <b>462</b> respectively, extend beyond tube passageway <b>484</b> and tube <b>441</b> to space first end <b>464</b> of vent line passageway <b>482</b> and vent line <b>462</b> away from tube passageway <b>484</b> and tube <b>441</b>.

Vent <b>460</b>, shown in <figref idref="DRAWINGS">FIGS. 29 and 30</figref>, comprises vent line <b>462</b>, filter <b>470</b>, and valve <b>472</b> as mentioned above. However, it is within the scope of this disclosure to provide any vent in communication with both vacuum space <b>453</b> and passageways <b>442</b> and with the surrounding atmosphere. In other words, a vent is provided for communication between an area outside bandage <b>410</b> and an area within bandage <b>410</b> below film <b>450</b> or any other sealing means to permit air to flow through the system to aspirate the passageways <b>442</b> of the system and to allow the system to operate as an open system. The vent <b>460</b> is provided to create a fluid flow path from outside the sealing means, through the sealing means to the member <b>419</b> and finally through the holes <b>446</b> and passageways <b>442</b> of the member <b>419</b> and out port <b>440</b> of member <b>419</b>.

The air from vent <b>460</b> flows within the wound space <b>453</b> below film <b>450</b>, or a similar sealing means, and above wound surface <b>413</b> of wound <b>200</b>. For example, some air from the surrounding atmosphere reaches passageways <b>442</b> through openings at the peripheral edges of member <b>419</b> and some reaches passageways <b>442</b> through holes <b>446</b> via various gaps which may exist between wound surface <b>413</b> of wound <b>200</b> and wound facing surface <b>424</b> of member <b>419</b>. Further, ribs, protrusions, nubs, or texturing on wound facing surface <b>424</b> act to promote air flow through holes <b>446</b> by providing a space between wound surface <b>413</b> and wound facing surface <b>424</b>.

Although vent <b>460</b> is provided to create a fluid flow path from the surrounding atmosphere through the passageways <b>442</b> of member <b>419</b> and out port <b>440</b> of member <b>419</b>, it is within the scope of this disclosure for vent line <b>462</b> of vent <b>460</b> to also be used as a separate irrigation line after filter <b>420</b> and valve <b>472</b> are detached from line <b>462</b>. This second line may be connected to the irrigation source <b>18</b>, for example, rather than be exposed to the surrounding atmosphere. It is therefore within the scope of this disclosure to connect second end <b>466</b> of vent line <b>462</b> to irrigation source <b>18</b> to permit irrigation of bandage <b>410</b> and wound surface <b>413</b> simultaneously with the operation of the vacuum source <b>16</b>.

Although this invention has been described in detail with reference to certain embodiments, variations and modifications exist within the scope and spirit of the invention as described and defined in the following claims.